Aneurysm TU, TR and RS modeling Concept Map
TAA and AAA Concept Map - TU/TR
Case 1 - Subject has both TAA and AAA
The subject had a chest CT scan and an abdominal CT scan.
TU Approach 1: TU result location findings are modeled as variables.
An evaluator examines the images of the thoracic and abdominal regions produced by the CT scan and decides whether TAA and AAA are present as well as their locations. Note for viewing simplicity, some variables are omitted from the table below.
ISSUE (CT/DOMAIN) Note the TUTEST here is: Aneurysm Location Identification, TUORRES = Located.
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TU Approach 2 - treating result location findings as individual tests
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Diameters of the identified aneurysms are measured and are mapped to TR. LNKID is used to link TU and TR.
ISSUE (DOMAIN) Note for Tumor Findings, it is recommended not to populate TRLOC because locations of tumors have been identified in TU. Should this rule be followed for non-tumor lesion? |
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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. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.
Questions and Thoughts
The results for TU, TUORRES = target, non-target, or new target. This convention was designed for tumor assessment. Target and non-target have very specific definitions depending on the tumor under study. Generally for solid tumor, according to RECIST:
Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan.
- All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.
Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques.
- All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.
Since TU is also shared by Lesion Identification, to have a result as "target" is misleading and doesn't always apply to non-tumor settings. When you say there is a target aneurysm, what does that mean? Target for treatment and response evaluation? what is the criteria that makes it a target? Usually an aneurysm larger than 5cm requires surgery. Does that mean the ones that are smaller than 5 cm are considered "non-target"? and non-target for what? surgery not needed? The values for TU responses right now, doesn't make sense for non-tumor lesion identification process.
Case 2 - Subject has AAA but TAA is not found
The subject had a MRI that scanned his torso, from chest to abdomen. Should PRLOC be "torso", or "chest" and "abdomen"? The places where you point the probe to, are they locations of the procedure?
The MRI scan produced cross-sectional images of the thoracic and abdominal regions of the subject. The evaluator then examined the MRI images of the thoracic region and abdominal region, and found the presence of a large AAA, and an aneurysm in the left renal artery, but the absence of TAA.
Because when a large AAA is found, the chance of a TAA (or an aneurysm developed elsewhere) is high (the reverse holds true as well), in the presence of a diagnosed large AAA or TAA, it is recommended to also screen for the other. A TAA is synchronous if diagnosed within 2 years from the diagnosis of an AAA. All TAAs diagnosed at a later date were considered metachronous and must have had prior chest imaging that did not show the presence of TAA.
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In the original DUKE data element, the responses provided for TAA and AAA, and all other types of aneurysms all have the responses: present, absent and unknown.
The example below models TAA and AAA according to the current TU domain structure. Note i am unable to map the negative identification record.
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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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