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

pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-123	1	CT SCAN	ABDOMEN	BASELINE

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

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVCAT	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1	AR	ABNIND	Abnormality Indicator	Abdominal region	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Aneurysm		Aneurysm	Aneurysm		Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3	AR-Aneurysm	LENGTH	Length		NON-TARGET FOR STUDY TREATMENT (MONITORING)	2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		NON-TARGET FOR STUDY TREATMENT (MONITORING)	2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

Dataset Debug Message

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CV NSV Metadata

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

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

The subject had a chest CT scan.

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pr.xpt

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	VISIT
1	ABC	PR	ABC-123	1	CT SCAN	CHEST	BASELINE

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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

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVCAT	CVORRES	CVSTRESC	CVSTRESN	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC	CVTUFLAG
1	ABC	CV	ABC-123	1	TR	ABNIND	Abnormality Indicator	Thoracic region	TARGET FOR STUDY TREATMENT	Y	Y	Y			CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic region	TARGET FOR STUDY TREATMENT	Aneurysm	Aneurysm	Aneurysm	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27	Y
3	ABC	CV	ABC-123	4	TR	ABNIND	Abnormality Indicator	Thoracic region	TARGET FOR STUDY TREATMENT	Y	Y	Y			CT SCAN	3	VISIT 2	2020-05-27
4	ABC	CV	ABC-123	5	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic region	TARGET FOR STUDY TREATMENT	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	Y

Dataset Debug Message

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CV NSV Metadata

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:

tu.xpt

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

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

tr.xpt

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

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Example 3: what the data should look like if there isn't a separate non-tumor lesion domain, whether or not the aneurysm is treated with a study intervention - what I have been trying to model all along. Pretend there is no TU/TR.

cv.xpt

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVCAT	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1	TR	ABNIND	Abnormality Indicator	Thoracic Region	TARGET FOR STUDY TREATMENT	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic Region	TARGET FOR STUDY TREATMENT	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	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Aneurysm		Aneurysm	Aneurysm		Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	TR-Aneurysm	LENGTH	Length		TARGET FOR STUDY TREATMENT	4	cm	4	4	cm			CT SCAN	1	BASELINE	2020-04-27
6	ABC	CV	ABC-123	6	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		TARGET FOR STUDY TREATMENT	5	cm	5	5	cm			CT SCAN	1	BASELINE	2020-04-27
7	ABC	CV	ABC-123	7	AR-Aneurysm	LENGTH	Length		NON-TARGET FOR STUDY TREATMENT (MONITORING)	2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
8	ABC	CV	ABC-123	8	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		NON-TARGET FOR STUDY TREATMENT (MONITORING)	2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

Dataset Debug Message

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CV NSV Metadata

Variable	Label	Type	Role	Origin
CVTNTSIN	Target/non-target for study intervention	text	Non-Standard Record Qualifier	CRF
CVTUFLAG	Flag for TU, TR or RS Data	text	Non-Standard Record Qualifier	CRF

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:

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

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

Example 3: what the data should look like if there isn't a separate non-tumor lesion domain, whether or not the aneurysm is treated with a study intervention - what I have been trying to model all along. Pretend there is no TU/TR.

What goes into TULOC?

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CV-imaging Example 2, Aneurysms and Arterial Dissection

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

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

Example 3: what the data should look like if there isn't a separate non-tumor lesion domain, whether or not the aneurysm is treated with a study intervention - what I have been trying to model all along. Pretend there is no TU/TR.

What goes into TULOC?