399 lines
14 KiB
JavaScript
399 lines
14 KiB
JavaScript
// Define the Trial Criteria Structure
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TrialCriteriaConstraints = {
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RECIST: RECIST,
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irRC: irRC
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};
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/**
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* RECIST 1.1 Trial Criteria Definition
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*
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* Baseline Checks:
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* - Extranodal lesions must be >/= 10 mm long axis AND >/= double the acquisition slice thickness by CT and MR
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* - Extranodal lesions must be >/= 20 mm on chest x-ray (although x-rays rarely used for clinical trial assessment)
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* - Nodal lesions must be >/= 15 mm short axis AND >/= double the acquisition slice thickness by CT and MR
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* - Up to a max of 2 target lesions per organ
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* - Up to a max of 5 target lesions total
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* - Non-targets can only be assessed as 'present'
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* - Target lesions must have measurements (cannot be assessed as CR, UN/NE, EX)
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* - Time Point Measurement Total = Sum of long axis measurements for extranodal target lesion + short axis measurements for nodal lesions
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*/
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function RECIST(image) {
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var acquisitionSliceThickness;
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if (image) {
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acquisitionSliceThickness = image.acquisitionSliceThickness;
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// TODO: Use metaData to determine if this is a chest X-ray
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var isChestXray = false;
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}
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// Define the RECIST 1.1 structure
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var criteria = {
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baseline: {
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target: {},
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nonTarget: {},
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group: {}
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}
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};
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if (acquisitionSliceThickness) {
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criteria.baseline.target.nodal = {
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(15, 2 * acquisitionSliceThickness),
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message: '^Nodal lesions must be >= 15 mm short axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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}
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};
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} else {
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criteria.baseline.target.nodal = {
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 15,
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//message: '^Nodal target lesions must be >= %{count} mm short axis'
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}
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}
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};
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}
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criteria.baseline.target.all = {
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// - Target lesions must have measurements (cannot be assessed as CR, UN/NE, EX)
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response: {
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exclusion: {
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within: {
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CR: 'Complete Response (CR)',
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UN: 'Unknown (UN)',
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NE: 'Non-evaluable (NE)',
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EX: 'Excluded (EX)'
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},
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message: '^Target lesions must have a length and cannot be marked as %{value} at baseline.'
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}
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},
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totalLesionBurden: {
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numericality: {
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greaterThanOrEqualTo: 2, // TODO: Check this, the value wasn't specified!
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//message: '^Total lesion burden (SPD target lesions + SPD new lesions) should be greater than %{count}.'
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}
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}
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};
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criteria.baseline.nonTarget.all = {
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// - Non-targets can only be assessed as 'present'
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response: {
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// This is a workaround since Validating equality to something is not implemented yet
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// https://github.com/ansman/validate.js/issues/79
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presence: {
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message: "^Non-target lesions can only be assessed as 'Present' at Baseline"
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},
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inclusion: {
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within: ['Present'],
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message: "^Non-target lesions can only be assessed as 'Present' at Baseline"
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}
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}
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};
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criteria.baseline.perOrgan = {
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numberOfLesionsPerOrgan: {
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numericality: {
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lessThanOrEqualTo: 2,
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//message: '^A maximum of %{count} target lesions per organ are allowed at Baseline.'
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}
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}
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};
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criteria.baseline.group = {
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totalNumberOfLesions: {
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numericality: {
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lessThanOrEqualTo: 5,
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//message: '^A maximum of %{count} target lesions total are allowed at Baseline.'
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}
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}
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};
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if (acquisitionSliceThickness) {
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criteria.baseline.target.extraNodal = {
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(10, 2 * acquisitionSliceThickness),
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message: '^Extranodal lesions must be >= 10 mm long axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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}
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};
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} else if (isChestXray) {
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criteria.baseline.target.extraNodal = {
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// -
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 20,
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//message: '^Extranodal lesions must be >= %{count} mm on chest X-ray'
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}
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}
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};
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} else {
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criteria.baseline.target.extraNodal = {
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 10,
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//message: '^Extranodal target lesions must be >= %{count} mm long axis'
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}
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}
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};
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}
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return criteria;
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}
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/**
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* irRC Trial Criteria Definition
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*
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* Baseline Checks:
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* - Target lesions must be >/= 10 X 10 mm
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* - Up to a max of 5 target lesions per organ
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* - Up to a max of 10 target lesions total
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* - Non-targets can only be assessed as 'present'
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* - Target lesions must have measurements (cannot be assessed as CR, UN/NE, EX)
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*/
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function irRC(image) {
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var acquisitionSliceThickness;
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if (image) {
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acquisitionSliceThickness = image.acquisitionSliceThickness;
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}
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// Define the irRC structure
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var criteria = {
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baseline: {
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target: {},
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nonTarget: {}
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},
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followup: {
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newLesions: {
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target: {}
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},
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target: {}
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},
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all: {}
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};
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if (acquisitionSliceThickness) {
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criteria.baseline.target.all = {
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(10, acquisitionSliceThickness),
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message: '^Target lesions must be >= 10 mm long axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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},
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(10, acquisitionSliceThickness),
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message: '^Target lesions must be >= 10 mm short axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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}
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};
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} else {
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criteria.baseline.target.all = {
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 10,
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//message: '^Target lesions must be >= %{count} mm long axis.'
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}
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},
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 10,
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//message: '^Target lesions must be >= %{count} mm short axis.'
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}
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}
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};
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}
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criteria.baseline.target.all.response = {
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exclusion: {
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within: {
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CR: 'Complete Response (CR)',
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UN: 'Unknown (UN)',
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NE: 'Non-evaluable (NE)',
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EX: 'Excluded (EX)'
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},
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message: '^^Target lesions must have a length and cannot be marked as %{value} at baseline.'
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}
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};
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criteria.baseline.nonTarget.all = {
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response: {
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// This is a workaround since Validating equality to something is not implemented yet
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// https://github.com/ansman/validate.js/issues/79
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presence: {
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message: "^Non-target lesions can only be assessed as 'Present' at Baseline"
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},
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inclusion: {
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within: ['Present'],
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message: "^Non-target lesions can only be assessed as 'Present' at Baseline"
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}
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}
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};
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criteria.baseline.perOrgan = {
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numberOfLesionsPerOrgan: {
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numericality: {
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lessThanOrEqualTo: 5,
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//message: '^A maximum of %{count} target lesions per organ are allowed at Baseline.'
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}
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}
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};
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criteria.baseline.group = {
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totalNumberOfLesions: {
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numericality: {
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lessThanOrEqualTo: 10,
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//message: '^A maximum of %{count} target lesions total are allowed at Baseline.'
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}
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}
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};
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if (acquisitionSliceThickness) {
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criteria.followup.newLesions.target.all = {
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// - New target lesions must be >/= 5 X 5 mm AND >/= double the acquisition slice thickness by CT and MR
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(5, 2 * acquisitionSliceThickness),
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message: '^New target lesions must be >= 5 mm long axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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},
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: Math.max(5, 2 * acquisitionSliceThickness),
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message: '^New target lesions must be >= 5 mm short axis AND >= double the acquisition slice thickness (' +
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acquisitionSliceThickness + ' mm) for CT and MR.'
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}
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}
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};
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} else {
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criteria.followup.newLesions.target.all = {
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// - New target lesions must be >/= 5 X 5 mm
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longestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 5,
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//message: '^New target lesions must be >= %{count} mm long axis.'
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}
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},
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shortestDiameter: {
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numericality: {
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greaterThanOrEqualTo: 5,
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//message: '^New target lesions must be >= %{count} mm short axis.'
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}
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}
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};
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}
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criteria.followup.group = {
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numberOfLesionsPerOrgan: {
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numericality: {
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lessThanOrEqualTo: 5,
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//message: '^A maximum of %{count} target lesions per organ are allowed at Followup.'
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}
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},
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totalNumberOfLesions: {
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numericality: {
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lessThanOrEqualTo: 10,
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//message: '^A maximum of %{count} target lesions total are allowed at Followup.'
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}
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}
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};
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// TODO: Check the actual requirement for total burden!
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criteria.all.group = {
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totalLesionBurden: {
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numericality: {
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greaterThanOrEqualTo: 100,
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//message: '^Total lesion burden (SPD target lesions + SPD new lesions) should be greater than %{count}.'
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}
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}
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};
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return criteria;
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}
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/**
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* Retrieve trial criteria constraints based on the image that measurements appear upon
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* If no image is specified, it is assumed that group or per Organ level criteria are desired.
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*
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* @param criteriaTypes An array of valid Trial Criteria set names (e.g. ['RECIST', 'irRC'])
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* NOTE: Multiple criteria are not yet supported
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*
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* @param imageId A Cornerstone Image ID
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* @returns {*} An Object of Trial Criteria that can be used to validate measurements' conformance
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*/
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getTrialCriteriaConstraints = function(criteriaTypes, imageId) {
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// TODO: update this when we allow multiple criteria
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var allCriteria = [];
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criteriaTypes.forEach(function(criteriaType) {
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if (!TrialCriteriaConstraints[criteriaType]) {
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throw 'No such Trial Criteria defined: ' + criteriaType;
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}
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// If no imageId was specified, skip customization of the criteria
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// and return the requested criteria right away
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var criteria;
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if (!imageId) {
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criteria = TrialCriteriaConstraints[criteriaType]();
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return criteria;
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}
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// Otherwise, retrieve the series metaData to identify the modality of the image
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var seriesMetaData = cornerstoneTools.metaData.get('series', imageId);
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if (!seriesMetaData) {
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return;
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}
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// TODO: Get the rest of the metaData that has already been loaded by Cornerstone
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var image = {};
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// If we are looking at an MR or CT image, we should pass the slice thickness
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// to the Trial Criteria functions so that they can customize the validation rules
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if (seriesMetaData.modality === 'MR' || seriesMetaData.modality === 'CT') {
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var instanceMetaData = cornerstoneTools.metaData.get('instance', imageId);
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image.acquisitionSliceThickness = instanceMetaData.sliceThickness;
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}
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// Retrieve the study metaData in order to find the timepoint type
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var studyMetaData = cornerstoneTools.metaData.get('study', imageId);
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if (!studyMetaData) {
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return;
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}
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// Retrieve the Study document from the Collection of associated Studies
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var study = Studies.findOne({
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studyInstanceUid: studyMetaData.studyInstanceUid
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});
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if (!study) {
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return;
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}
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// Find the related Timepoint document
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var timepoint = Timepoints.findOne({
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timepointId: study.timepointId
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});
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if (!timepoint) {
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log.warn('Timepoint related to study is missing.');
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return;
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}
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// Retrieve the Timepoint's type (e.g. 'baseline' or 'followup')
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var timepointType = timepoint.timepointType;
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// Obtain the customized trial criteria given the image metaData
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criteria = TrialCriteriaConstraints[criteriaType](image);
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// Return the relevant criteria given the current timepoint type
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allCriteria.push(criteria[timepointType]);
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});
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return allCriteria[0];
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};
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