Example 1: Observed abnormality that's also a lesion "target" for study intervention

The subject had a chest CT scan and an abdominal 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
2	ABC	PR	ABC-123	2	CT SCAN	ABDOMEN	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 lesion for study intervention, tracking and/or disease response to treatment assessment.

cv.xpt

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVSTRESC	CVSTRESN	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC	TUFLAG
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-Dissection	ABNEXAM	Examination for Abnormality	Thoracic region	Arterial Dissection	Arterial Dissection	Arterial Dissection	Descending aorta		CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	TR-Aneurysm	TARGSINT	Target for Study Intervention		Target	Target	Target			CT SCAN	1	BASELINE	2020-04-27	Y
5	ABC	CV	ABC-123	5	TR-Dissection	TARGSINT	Target for Study Intervention		Target	Target	Target			CT SCAN	1	BASELINE	2020-04-27	Y

Dataset Debug Message

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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
2	ABC	TU	ABC-123	2	TR-Dissection		Lesion (Role) Identification	Descending aorta		Target	Target	CT SCAN	1	BASELINE	2020-04-27

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Shows the diameter measurements of the target lesion in TR:

tu.xpt

tr.xpt

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

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Example 2: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is managed by a non-study drug (e.g. beta blockers, hypertension drug).

cv.xpt

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	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	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	5	AR-Aneurysm		Target for Study Intervention		non-target for study intervention		non-target for study intervention	non-target for study intervention					1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	3	AR-Aneurysm	LENGTH	Length		2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	4	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

Dataset Debug Message

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The dissected descending aorta (LNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.

Note: This test was originally created as a CVTEST, based on SDTMIG 3.4, this is now considered as a grading scale and therefore should now be represented as CC/RS.

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rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	VISITNUM	VISIT	CVDTC
1	ABC	RS(CC)	ABC-123	1	1	STAN0101	STAN01-Stanford Aortic Dissection Classification Type	STANFORD AOD CLASSIFICATION	STANFORD B	STANFORD B	1	BASELINE	2020-04-27

Dataset Debug Messages

There seem to be multiple domains (RS(CC)) present in the dataset.
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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 "target" for study intervention

Example 2: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is managed by a non-study drug (e.g. beta blockers, hypertension drug).

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 "target" for study intervention

Example 2: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is managed by a non-study drug (e.g. beta blockers, hypertension drug).

What goes into TULOC?