CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Imaging Diagnostics
CRF: Imaging Analysis Technique and Results - Baseline

Displaying 51 - 80 of 80
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C15445 Imaging cortical thickness measurement ImgCortThiMeasr Thickness of cerebral cortex measurement Thickness of cerebral cortex measurement Cortical thickness Numeric Values

Record in mm and use 2 decimal places.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

millimeter
C18999 Imaging T2W image technique other text ImgT2WImgTechOTH The free-text field related to 'Imaging T2W image technique type' specifying other text. Method used to determine the total volume of white matter hyperintensities on T2-weighted image The free-text field related to 'Imaging T2W image technique type' specifying other text. Method used to determine the total volume of white matter hyperintensities on T2-weighted image Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 4000

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C15376 Imaging other unspecified lesion count ImgOthUnspecLesnCt Total number of other lesions whose type is not specified Total number of other lesions whose type is not specified Number of other lesions whose type is not specified Numeric Values

Exploratory for Imaging studies

No additional instructions

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

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C15472 Imaging diffusion measurement type ImgDiffusionMeasrTyp Type of diffusion tensor imaging (DTI) measurement Type of diffusion tensor imaging (DTI) measurement N/A Mean FA;Mean ADC;Mean axial diffusivity;Mean radical diffusivity;Other, specify Mean FA;Mean ADC;Mean axial diffusivity;Mean radical diffusivity;Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15415 Imaging gray matter volume measurement ImgGrayMattVolMeasr Volume of the gray matter Volume of the gray matter Gray matter volume Numeric Values

Exploratory for Imaging studies

Answer questions and sub-questions for gray matter volume, or gray matter volume fraction but not both. Record in mL and use 2 decimal places. Acceptable range is 20.00 - 2000.00.

This element is considered exploratory for imaging study.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

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20 2000 milliliter
C15516 Imaging tissue integrity normal appearing white matter measurement indicator ImgTissueIntegApprWMInd Whether measurements of the tissue integrity of normal appearing white matter were taken. Whether measurements of the tissue integrity of normal appearing white matter were taken. Normal Appearing WM Yes;No;Unknown Yes;No;Unknown Alphanumeric

Answer for all tissue integrity types.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15321 Imaging T2W brain lesion volume measurement ImgT2wBrnLesnVolMeasr Total volume of all focal T2-hyperintense brain lesions Total volume of all focal T2-hyperintense brain lesions Total volume of brain lesions on T2W image Numeric Values

Highly recommended for: Imaging studies

Record total volume of white matter lesions on T2W image in cc. Use 2 decimal places. Expected range 0 - 1000.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

0 1000 cubic centimeter
C15446 Imaging ventricular volume technique type ImgVentrclVolTechTyp Image analysis method used to calculate ventricular volume Image analysis method used to calculate ventricular volume Technique Used Automated;Manual;Semi-automated Automated;Manual;Semi-automated Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C19000 Imaging Gadolinium-enhancing lesion technique other text ImgGdEnLesnTechOTH The free-text field related to 'Imaging Gadolinium-enhancing lesion technique type' specifying other text. Method used to determine the lesions for gadolinium (Gd)-enhancing lesions on T1+Gd image The free-text field related to 'Imaging Gadolinium-enhancing lesion technique type' specifying other text. Method used to determine the lesions for gadolinium (Gd)-enhancing lesions on T1+Gd image Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 4000

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C15379 Imaging T2W image technique type ImgT2WImgTechTyp Method used to determine the total volume of white matter hyperintensities on T2-weighted image Method used to determine the total volume of white matter hyperintensities on T2-weighted image Technique Used Manual tracing;Semi-automated (verified by experienced reader);Fully automated segmentation (verified by experienced reader);Other, specify Manual tracing;Semi-automated (verified by experienced reader);Fully automated segmentation (verified by experienced reader);Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15474 Imaging diffusion result value ImgDiffusionReslt The numeric value for diffusion tensor imaging (DTI) result The numeric value for diffusion tensor imaging (DTI) result N/A Numeric Values

Record a value for each diffusion tensor imaging (DTI) measure and each region of the brain.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

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C15418 Imaging gray matter volume fraction value ImgGrayMattVolFractVal Volume of gray matter in the brain or ratio of gray matter volume to total intracranial volume or other head-size normalization volume Ratio of gray matter volume to total intracranial volume or other head-size normalization volume Gray matter volume fraction Numeric Values

Exploratory for Imaging studies

Answer questions and sub-questions for gray matter volume, or gray matter volume fraction but not both. Use 4 decimal places. Acceptable range is 0.2000 - 0.8000.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

0.2 0.8
C15517 Imaging tissue integrity normal appearing gray matter measurement indicator ImgTissueIntegApprGrayMttrInd Whether measurements of the tissue integrity of normal appearing gray matter were taken. Whether measurements of the tissue integrity of normal appearing gray matter were taken. Normal Appearing GM Yes;No;Unknown Yes;No;Unknown Alphanumeric

Answer for all tissue integrity types.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15329 Imaging T2 lesion total count performed indicator ImgT2LesnTtlCtPerfInd Whether total counts of the number of focal T2-hyperintense brain lesions was performed Whether total counts of the number of focal T2-hyperintense brain lesions was performed Total T2 lesion counts Done;Not done Done;Not done Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15449 Imaging hippocampus volume measurement ImgHippoVolMeasr Hippocampus volume measurement Hippocampus volume measurement Hippocampus Numeric Values

Record in mL and use 2 decimal places.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

milliliter
C19001 Imaging T1 hypointense lesion technique other text ImgT1HypinLesnTechOTH The free-text field related to 'Imaging T1 hypointense lesion technique type' specifying other text. Method used to determine the total number of T1 hypointense lesions The free-text field related to 'Imaging T1 hypointense lesion technique type' specifying other text. Method used to determine the total number of T1 hypointense lesions Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 4000

Free-Form Entry

C15381 Imaging Gadolinium-enhancing lesion total volume measurement ImgGdEnLesnTtlVolMeasr Total volume of all focal lesions that are gadolinium (Gd)-enhancing on T1-weighted brain images Total volume of all focal lesions that are gadolinium-enhancing on T1-weighted brain images Total volume of Gd-enhancing lesions Numeric Values

Record total volume of Gd-enhancing lesions in cc. Use 2 decimal places. Expected range 0 - 1000.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

0 1000 cubic millimeter
C15478 Imaging gray matter lesion technique type ImgGrayMattLesnTechTyp Method used to determine the number of lesions Method used to determine the number of lesions Technique Used Visual determination by experienced reader;Semi-automated (calculated through software, verified by experienced reader);Fully automated segmentation, localization, and counting;Other, specify Visual determination by experienced reader;Semi-automated (calculated through software, verified by experienced reader);Fully automated segmentation, localization, and counting;Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15420 Imaging brain volume technique type ImgBrainVolTechTyp Image analysis method used to calculate whole brain volume Image analysis method used to calculate whole brain volume Technique Used Other, specify;Absolute brain volume (non-normalized);Normalized brain volume (e.g., SIENAX) Other, specify;Absolute brain volume (non-normalized);Normalized brain volume (e.g., SIENAX) Alphanumeric

Absolute brain volume = straight volume measurement with no normalization for head size. Normalized brain volume = techniques which calculate volume after transformation to standard space

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15518 Imaging tissue integrity other regional measurements indicator ImgTissueIntegRegnlMeasInd Whether measurements of the tissue integrity of other brain regions were taken. Whether measurements of the tissue integrity of other brain regions were taken. Other Regional Measurements Yes;No;Unknown Yes;No;Unknown Alphanumeric

Answer for all tissue integrity types.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15338 Imaging T2 lesion total count ImgT2LesnTtlCt Total number of focal T2-hyperintense brain lesions Total number of focal T2-hyperintense brain lesions Total number of T2 lesions Numeric Values

Highly recommended for: Clinical trials of disease-modifying therapies.

Range of 0 - 1000.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

0 1000
C15453 Imaging thalamus volume measurement ImgThalVolMeasr Thalamus volume measurement Thalamus volume measurement Thalamus Numeric Values

Record in mL and use 2 decimal places.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

milliliter
C19002 Imaging brain volume technique other text ImgBrainVolTechOTH The free-text field related to 'Imaging brain volume technique type' specifying other text. Image analysis method used to calculate whole brain volume The free-text field related to 'Imaging brain volume technique type' specifying other text. Image analysis method used to calculate whole brain volume Other, specify Alphanumeric

Absolute brain volume = straight volume measurement with no normalization for head size. Normalized brain volume = techniques which calculate volume after transformation to standard space

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 4000

Free-Form Entry

C15386 Imaging Gadolinium-enhancing lesion technique reference name ImgGdEnLesnTeRefName Name of software package used, website, and/or a citation to a journal article referencing the particular technique used to find Gadolinium-enhancing lesions. Name of software package used, website, and/or a citation to a journal article referencing the particular technique used. Technique reference (i.e. literature citation(s), MRI Acquisition Manual or Analysis Manual) Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 255

Free-Form Entry

C15490 Imaging regional brain volume technique type ImgRegBrainVolTechTyp Image analysis method used to calculate other regional volume or regional volume fractions Image analysis method used to calculate other regional volume or regional volume fractions Technique Used Brain structure volumes;Central cerebral volume;Cortical thickness Brain structure volumes;Central cerebral volume;Cortical thickness Alphanumeric

Exploratory for Imaging studies

Complete as many times as needed.

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15423 Imaging gray matter lesion count ImgGrayMattLesnCt Total number of brain lesions located in the gray matter or lesions in the subcortical white matter also involving the gray matter Total number of brain lesions located in the gray matter or lesions in the subcortical white matter also involving the gray matter Total number of gray matter lesions Numeric Values

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

C15646 Imaging posterior fossa lesion count ImgPostrFossaLesnCt Total number of focal T2-hyperintense brain lesions that are in contact with the posterior fossa (brainstem or cerebellum) Total number of focal T2-hyperintense brain lesions that are in contact with the posterior fossa (brainstem or cerebellum) Number of posterior fossa lesions Numeric Values

Expected range 0 - 1000.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Free-Form Entry

0 1000
C15346 Imaging regional T2 lesion count performed indicator ImgRgnlT2LesnCntPerfInd Whether regional T2 lesion counts were performed Whether regional T2 lesion counts were performed Regional T2 lesion counts Done;Not done Done;Not done Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

Single Pre-Defined Value Selected

C15457 Imaging spinal cord lesion count ImgSpinCordLesnCt Total number of lesions located at any level of the spinal cord Total number of lesions located at any level of the spinal cord Total number of spinal cord lesions Numeric Values

Exploratory for Imaging studies

No additional instructions

No references available Adult;Pediatric Exploratory 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations

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C19003 Imaging brain volume fraction technique other text ImgBrainVolFractTechOTH The free-text field related to 'Imaging brain volume fraction technique type' specifying other text. Image analysis method used to calculate whole brain volume fraction The free-text field related to 'Imaging brain volume fraction technique type' specifying other text. Image analysis method used to calculate whole brain volume fraction Other, specify Alphanumeric

No additional instructions

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Imaging Analysis Technique and Results - Baseline Imaging Diagnostics Assessments and Examinations 4000

Free-Form Entry

CSV