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The below concept map shows the impact of creating a separate non-tumor lesion domain (which uses the original tumor domain structure) and how it affects modeling:



Example 1: Mapping the entire cardiovascular abnormality identification process in CV.

Two aneurysms are identified in the thoracic and abdominal regions.

CVLNKGRP provides the unique identifier for each identified aneurysm

cv.xpt

ROW

STUDYID

DOMAIN

USUBJID

CVSEQ

CVGRPIDCVLNKGRPCVLNKIDCVTESTCD

CVTEST

CVLOC

CVORRES

CVORRESUCVSTRESCCVSTRESNCVSTRESUCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC

1ABCCVABC-1231


ABNINDAbnormality IndicatorThoracic RegionY
YY


CT SCAN

1BASELINE2020-04-27
2ABCCVABC-1232TargetA1Aneurysm 1ABNEXAMExamination for AbnormalityThoracic RegionAneurysm
AneurysmAneurysm
Thoracic AortaAortic Arch to Descending aorta

CT SCAN

1BASELINE2020-04-27
3ABCCVABC-1233


ABNINDAbnormality IndicatorAbdominal regionY
YY


CT SCAN

1BASELINE2020-04-27
4ABCCVABC-1234Non-Target
Aneurysm 2ABNEXAMExamination for AbnormalityAbdominal regionAneurysm
AneurysmAneurysm
Infrarenal aortaproximal to the iliac bifurcation

CT SCAN

1BASELINE2020-04-27
5ABCCVABC-1235TargetA1Aneurysm 1ABNROIDAbnormality (Role) Identification
Target for study intervention
Target for study interventionTarget for study intervention


CT SCAN

1BASELINE2020-04-27
6ABCCVABC-1236Non-Target
Aneurysm 2ABNROIDAbnormality (Role) Identification
Non-target for study intervention, monitor progression
Non-target for study intervention, monitor progressionNon-target for study intervention, monitor progression


CT SCAN

1BASELINE2020-04-27
7ABCCVABC-1237TargetA1Aneurysm 1LENGTHLength
4cm44cm

CT SCAN

1BASELINE2020-04-27
8ABCCVABC-1238TargetA1Aneurysm 1MAXLDIAMaximal Luminal Diameter
5cm55cm

CT SCAN

1BASELINE2020-04-27
9ABCCVABC-1239Non-Target
Aneurysm 2LENGTHLength
2cm22cm

CT SCAN

1BASELINE2020-04-27
10ABCCVABC-12310Non-Target
Aneurysm 2MAXLDIAMaximal Luminal Diameter
2.5cm2.52.5cm

CT SCAN

1BASELINE2020-04-27
$warningHtml

Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.

pr.xpt

pr.xpt

Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

1  ABCPR  ABC-1231CT SCANABDOMENBASELINE

Dataset Debug Message

There are four leading, trailing, or non-breaking spaces in the dataset.

A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention even though it can be considered as a lesion, it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysm. 

cv.xpt

cv.xpt

ROW

STUDYID

DOMAIN

USUBJID

CVSEQCVGRPIDCVTESTCD

CVTEST

CVLOC

CVCAT

CVORRES

CVORRESUCVSTRESCCVSTRESNCVSTRESUCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


CVTUFLAG
1ABCCVABC-1231ARABNINDAbnormality IndicatorAbdominal regionNON-TARGET FOR STUDY TREATMENT (MONITORING)Y
YY


CT SCAN

1BASELINE2020-04-27

2ABCCVABC-1232AR-AneurysmABNEXAMExamination for AbnormalityAbdominal regionNON-TARGET FOR STUDY TREATMENT (MONITORING)Aneurysm
AneurysmAneurysm
Infrarenal aortaproximal to the iliac bifurcation

CT SCAN

1BASELINE2020-04-27

3ABCCVABC-1233AR-AneurysmLENGTHLength
NON-TARGET FOR STUDY TREATMENT (MONITORING)2cm22cm

CT SCAN

1BASELINE2020-04-27

4ABCCVABC-1234AR-AneurysmMAXLDIAMaximal Luminal Diameter
NON-TARGET FOR STUDY TREATMENT (MONITORING)2.5cm2.52.5cm

CT SCAN

1BASELINE2020-04-27

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

CV NSV Metadata

Example 2: Observed abnormality that's also a lesion and "target" for study intervention

The subject had a chest CT scan.

$titleHtml

pr.xpt

Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRLOC

VISIT

 1  ABCPR  ABC-1231CT SCANCHESTBASELINE
$warningHtml
The chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention. Note the use of the NSV TUFLAG to show that this abnormality is also considered as a target lesion for study intervention, tracking and/or disease response to treatment assessment. When the TUFLAG is marked with Y, measurements of the lesion should be represented in TU, TR and/or RS.

cv.xpt

cv.xpt

ROW

STUDYID

DOMAIN

USUBJID

CVSEQ

CVLNKIDCVTESTCD

CVTEST

CVLOC

CVCAT

CVORRES

CVSTRESCCVSTRESNCVRESLOCCVRLODTL

CVMETHOD

VISITNUM

VISIT

CVDTC


CVTUFLAG
1ABCCVABC-1231TRABNINDAbnormality IndicatorThoracic regionTARGET FOR STUDY TREATMENTYYY

CT SCAN

1BASELINE2020-04-27

2ABCCVABC-1232TR-AneurysmABNEXAMExamination for AbnormalityThoracic regionTARGET FOR STUDY TREATMENTAneurysmAneurysmAneurysmThoracic AortaAortic Arch to Descending aorta

CT SCAN

1BASELINE2020-04-27
Y
3ABCCVABC-1234TRABNINDAbnormality IndicatorThoracic regionTARGET FOR STUDY TREATMENTYYY

CT SCAN

3VISIT 22020-05-27

4ABCCVABC-1235TR-AneurysmABNEXAMExamination for AbnormalityThoracic regionTARGET FOR STUDY TREATMENTAneurysm decreased in sizeAneurysm decreased in size

Aneurysm decreased in size

Thoracic AortaAortic Arch to Descending aorta

CT SCAN

3VISIT 22020-05-27
Y
$warningHtml

CV NSV Metadata

Shows the TU representation of the target lesions:

tu.xpt

tu.xpt

Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKIDTUTESTCD

TUTEST

TULOC

TULOCDTL

TUORRES

TUSTRESC

TUMETHOD

VISITNUM

VISIT

TUDTC

1ABCTUABC-1231TR-Aneurysm
Lesion (Role) IdentificationThoracic AortaAortic Arch to Descending aortaTargetTarget

CT SCAN

1BASELINE2020-04-27
$warningHtml
Show the diameter measurements of the target lesion in TR at two visits:

tr.xpt

tr.xpt

Row

STUDYID

DOMAIN

USUBJID

TRSEQTRLNKIDTRTESTCD

TRTEST

TRORRES

TRORRESU

TRSTRESC

TRSTRESN

TRSTRESU

VISITNUM

VISIT

TUDTC

1ABCTRABC-1231TR-AneurysmLENGTHLength4cm44cmcmBASELINE2020-04-27
2ABCTRABC-1232TR-AneurysmMAXLDIAMaximal Luminal Diameter5cm55cmcmBASELINE2020-04-27
3ABCTRABC-1233TR-AneurysmLENGTHLength2cm22cmcmVISIT 22020-05-27
4ABCTRABC-1234TR-AneurysmMAXLDIAMaximal Luminal Diameter3cm33cmcmVISIT 22020-05-27
$warningHtml

The TU/TR/RS domains were created for tumors which in themselves don't belong in any body system domains (tumor can grow and spread to any place), hence they are in their own domains. At some point, non-tumor lesion was added to TU/TR. SDTM now has body-system domains, it then begs the question whether a separate non-tumor lesion domain is needed, when most "lesions" and things that could be considered as lesions, can go into their respective body-system domains. Can the body system domains offer the "unique lesion identifier" through the use of, GRPID, REFID, or other identifier variables?



What goes into TULOC?

After all this, i struggle with what values should go into TULOC. When a CT scans the chest, it produces cross-sectional images of the chest/thorax and everything in it. You can view the images in three angles: a) axial view (you are looking at the picture of the thorax from the direction of head to toe), b) the coronal view (you are looking at the images of the thorax as if you are standing in front of the person),  c) sagittal view (you are looking at the picture of the thorax from the side). Hence TULOCs are populated with Thoracic Region and Abdominal Region for now. Especially in the axial view, as you move from cross-sectional images of the thorax to images of the abdomen, you are looking at sectioned images of the thoracic region to abdominal region, there is no mistake about which region you are looking at because the anatomy of both regions are so different and clearly sperpated. I think it is not wrong to populate TULOC with chest and abdomen as well, they are just not the most precise anatomical terms.

Questions and Thoughts

Imaging modality for the CV-imaging project:

Coronary angiography:

  1. Done on the chest area, the probe rotates around the chest of the subject, but there is no such a thing as "chest Coronary angiography", it is simply called Coronary angiography.
  2. Creates images of the entire coronary artery system.
  3. We don't record PRLOC = chest for this procedure

Thransthoracic Echocardiogram (TTE):

  1. Done on the chest and upper abdominal wall. The transducer is placed on various parts of the chest and upper belly to create ultrasonic views different views of the heart. Again, there is no such a thing as chest TTE.
  2. Creates images of the heart.
  3. We don't record PRLOC = Chest and upper abdomen for this procedure

Transesophageal Echocardiogram (TEE):

  1. Transducer is inserted into the Esophagus.
  2. Creates images of the heart.
  3. We don't record PRLOC = Esophagus

Cine Angiography:

  1. Done on the chest, again the probe is placed on top of the chest.
  2. Creates images of the entire coronary artery system.

In addition, i just recently took a family member to have a Thyroid Ultrasound:

  1. The ultrasound probe moved around her neck
  2. Creates images of the thyroid gland. In this case would you argue that PRLOC is thyroid or neck?

Referring to Richard M's email:

LOC in the interventions class is "Anatomical focus of an intervention - at which part of the body an intervention is being made". This also my understanding as well.

  • The "injection" intervention has an anatomical focus - the anatomical site of injection.
  • Percutaneous Coronary Intervention (also known as angioplasty with stent), has an anatomical location where the procedure occurs, intervenes and alters the abnormal structure of the location - i.e. in the RIGHT POSTERIOR DESCENDING ARTERY (PRLOC), the angioplasty breaks up the blockage and inserts a stent.
  • Brachytherapy places radioactive material inside a location of the body to kill cancer cells, e.g. prostate. The procedure occurs, intervenes and alters the abnormal structure of the location.

It is easy to pinpoint a location for invasive/treatment type interventions and this aligns with my understanding of how PRLOC should be used.

However, for "diagnostic imaging" procedures, where the imaging probe is placed (i.e. neck, chest, abdomen, head, etc.), Is this really the location where a intervention is "made"?

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