A concept map that helps me to understand all the questions and the impact of a separate non-tumor lesion domain:

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CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Question 1: just because something is considered as a lesion, does that mean that it should be mapped to the lesion domains?

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

Two aneurysms are identified in the thoracic and abdominal regions, one is considered as "target" for study treatment and the other "non-target" for study treatment.

CVLNKID provides the unique identifier for each identified aneurysm.

LNKGRP will link the CV records to other domain datasets, such as RS and CC for disease response to treatment and clinical classification data (data not shown).

Dataset2

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVLNKGRP	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1			TR	ABNIND	Abnormality Indicator	Thoracic Region	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	Target	A1	TR- Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic Region	Aneurysm		Aneurysm	Aneurysm		Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3			AR	ABNIND	Abnormality Indicator	Abdominal region	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	Non-Target		AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	Aneurysm		Aneurysm	Aneurysm		Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	Target	A1	TR- Aneurysm	ABNROID	Abnormality (Role) Identification		Target for study intervention		Target for study intervention	Target for study intervention				CT SCAN	1	BASELINE	2020-04-27
6	ABC	CV	ABC-123	6	Non-Target		AR-Aneurysm	ABNROID	Abnormality (Role) Identification		Non-target for study intervention, monitor progression		Non-target for study intervention, monitor progression	Non-target for study intervention, monitor progression				CT SCAN	1	BASELINE	2020-04-27
7	ABC	CV	ABC-123	7	Target	A1	TR- Aneurysm	LENGTH	Length		4	cm	4	4	cm			CT SCAN	1	BASELINE	2020-04-27
8	ABC	CV	ABC-123	8	Target	A1	TR- Aneurysm	MAXLDIA	Maximal Luminal Diameter		5	cm	5	5	cm			CT SCAN	1	BASELINE	2020-04-27
9	ABC	CV	ABC-123	9	Non-Target		AR-Aneurysm	LENGTH	Length		2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
10	ABC	CV	ABC-123	10	Non-Target		AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

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?

Question 2: how do you map lesions that are non-target for study treatment?

TU/TR/RS were originally built to assess tumor response to "study" treatment. Both "target" and "non-target" tumors receive the same study treatment, are then tracked and evaluated. "Target" and "non-target" tumor properties are mapped to TR and their responses to treatment are mapped to RS. Depending on the criteria used, "Target" and "non-target" tumor responses to treatment are evaluated a little differently. "Non-target" in the tumor context, does NOT mean, "not treated by study intervention".

In the CV data element projects, non-target is used to describe a lesion that will NOT be treated by a study intervention. Such a lesion may be untreated, managed by a non-study drug, or treated with a non-study device or procedure. This type of data has also been mapped into TU and TR, is this correct? If TU/TR are built to house lesion response to study treatment type of data, then I think the CV modeling is incorrect, and if so, how do we deal with it?

Example 2: Observed abnormality that's a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.

A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention, it is untreated and continuously monitored. Not sure whether this can be mapped to TU/TR, hence mapped to CV.

Dataset wrap

title	cv.xpt
Name	cv

Dataset2

hi3	TURESLOC
hi2style	yellow
hi3style	BOLD

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1		AR	ABNIND	Abnormality Indicator	Abdominal region	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	NON-TARGET	AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	Aneurysm		Aneurysm	Aneurysm		Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3	NON-TARGET	AR-Aneurysm	ABNROID	Abnormality (Role) Identification		Non-target for study intervention, monitor progression		Non-target for study intervention, monitor progression	Non-target for study intervention, monitor progression				CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	NON-TARGET	AR-Aneurysm	LENGTH	Length		2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	NON-TARGET	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

Nsvmeta

Domain	CV

Variable	Label	Type	Role	Origin
CVTUFLAG	Flag for TU, TR or RS Data	text	Non-Standard Record Qualifier	CRF

Example 3: Observed abnormality that's also a lesion and "target" for study intervention

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.

Dataset wrap

title	cv.xpt
Name	cv

Dataset2

tableid	CV 2

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVSTRESC	CVSTRESN	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC	CVTUFLAG
1	ABC	CV	ABC-123	1	TR	ABNIND	Abnormality Indicator	Thoracic region	Y	Y	Y			CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic region	Aneurysm	Aneurysm	Aneurysm	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3	TR-Aneurysm	ABNROID	Abnormality (Role) Identification		Target for study intervention	Target for study intervention	Target for study intervention			CT SCAN	1	BASELINE	2020-04-27	Y
4	ABC	CV	ABC-123	4	TR	ABNIND	Abnormality Indicator	Thoracic region	Y	Y	Y			CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic region	Aneurysm decreased in size	Aneurysm decreased in size	Aneurysm decreased in size	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	3	VISIT 2	2020-05-27

Nsvmeta

Domain	CV

Variable	Label	Type	Role	Origin
CVTUFLAG	Flag for TU, TR and/or RS Data	text	Non-Standard Record Qualifier	CRF

Shows the TU representation of the target lesions:

Dataset wrap

title	cv.xpt
Name	TU

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TULOC	TULOCDTL	TUORRES	TUSTRESC	TUMETHOD	VISITNUM	VISIT	TUDTC
1	ABC	TU	ABC-123	1	TR-Aneurysm		Lesion (Role) Identification	Thoracic Aorta	Aortic Arch to Descending aorta	Target	Target	CT SCAN	1	BASELINE	2020-04-27

Show the diameter measurements of the target lesion in TR at two visits:

Dataset wrap

title	cv.xpt
Name	TR

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	VISITNUM	VISIT	TUDTC
1	ABC	TR	ABC-123	1	TR-Aneurysm	LENGTH	Length	4	cm	4	4	cm	cm	BASELINE	2020-04-27
2	ABC	TR	ABC-123	2	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	5	cm	5	5	cm	cm	BASELINE	2020-04-27
3	ABC	TR	ABC-123	3	TR-Aneurysm	LENGTH	Length	2	cm	2	2	cm	cm	VISIT 2	2020-05-27
4	ABC	TR	ABC-123	4	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	3	cm	3	3	cm	cm	VISIT 2	2020-05-27

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.

Info

title	Questions and Thoughts

Imaging modality for the CV-imaging project:

Coronary angiography:

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.
Creates images of the entire coronary artery system.
We don't record PRLOC = chest for this procedure

Thransthoracic Echocardiogram (TTE):

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.
Creates images of the heart.
We don't record PRLOC = Chest and upper abdomen for this procedure

Transesophageal Echocardiogram (TEE):

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

Cine Angiography:

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

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

The ultrasound probe moved around her neck
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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CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Question 1: just because something is considered as a lesion, does that mean that it should be mapped to the lesion domains?

Question 2: how do you map lesions that are non-target for study treatment?

Example 3: Observed abnormality that's also a lesion and "target" for study intervention

What goes into TULOC?

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Include PageCT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study InterventionCT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Question 1: just because something is considered as a lesion, does that mean that it should be mapped to the lesion domains?

Question 2: how do you map lesions that are non-target for study treatment?

Example 3: Observed abnormality that's also a lesion and "target" for study intervention

What goes into TULOC?

Include Page
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention