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titleQuestions 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 really 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.

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titleQuestions and Thoughts

I wonder what the LOC truly is in this procedure, or whether you need a value in PRLOC at all, because essentially, you are doing a Chest MRI, followed by abdominal MRI (or vise versa) - the MRI scans and take cross-sectional pictures of your chest and abdomen. If the scanning is done on the same day in one visit, would you consider the scan of the chest a separate procedure from the scan of the abdomen? This is why for "diagnostic procedures" procedure, I think the location where the procedure is done is irrelevant. When we say Chest CT, or Chest MRI, does this mean the CT scan is done on the chest (hence PRLOC), or does it mean that the purpose of the CT scan is to scan and create images of the chest, aka the thoracic region? I think this is where the confusion isconfusing.


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STUDYID

DOMAIN

USUBJID

PRSEQ

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PRLOC

VISIT

 1  ABCPR  ABC-4561MRITrunkBASELINE



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