Talk:Imaging biomarker

Untitled

This article requires major editing.

Most importantly, it is misleading the reader in:

1) giving a very loose definition of the imaging biomarker. The strict definition is: "characteristics that are objectively measured and evaluated as indicators of normal biologic processes, pathological processes, or biological responses to a therapeutic intervention" [1].

2) claiming RECIST as a biomarker. RECIST is not a biomarker, tumor shrinkage is. RECIST is a tumor shrinkage response criteria considered appropriate by the FDA [2].

3) creating impression that there is a number of established imaging biomarkers, while in fact there is not a single one approved by regulatory agencies [3].

I do not have time to edit this extensively at the moment, but at the very least this note should be here to hopefully help the reader.

[1] U.S. Food and Drug Administration (2010) Guidance for Industry: Qualification Process for Drug Development Tools. Silver spring, MD: Center for Drug Evaluation and Research (CDER) 1-19.

[2] http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf

[3] Sanjay S. Imaging Biomarkers in Drug Development. Journal of Biomarkers in Drug Development. 2012; Available: http://www.scitechnol.com/JBDD/JBDD-1-e102.php?article_id=230

Quantitative Imaging Biomarkers

I started to make some edits here, added information rather than removing. I agree with the above author that RECIST isn't really quantitative, no matter how much some radiologists claim it is (but we get a number!). It is not objective, and doesn't tie into a hard physical measurand because it requires careful selection and tracking of lesions, plus a sketchy two-axis measurement. I've tried to provide some better examples and some recent publications that speak better towards actual physical QIBs as used in molecular imaging and MRI.

This needs a lot of work still. Patarroyo (talk) 21:22, 25 October 2024 (UTC)

Organizations

This entire section is dated and/or irrelevant. UPICT has been dead for over a decade. There is no mention of QIBA, which is astounding. Worse, QIBA has since been dissolved, leaving a gaping hole in this critical area. No mention of J-QIBA in Japan. No mention of QIN.

I would like to take ownership of this page. I am well-connected in the quantitative imaging community and feel that there are a large number of individuals who can and would be willing to make substantive contributions here. As it stands, this entry seems very lackluster and abandoned. Patarroyo (talk) 21:43, 25 October 2024 (UTC)

General

There is a need to further refine the definition of imaging biomarker, as what is being discussed here is really **medical** imaging biomarkers, vs. the type of imaging biomarkers one might see via fluorescence imaging/microscopy or even under optical microscopy.

Engagement with individuals at the FDA, EMA, metrological institutes (PTB, KRISS, NPL, INSERM, NIST) select professional societies (IPEM, AAPM, JRS, ESR, SNMMI, ISMRM, AIUM, etc.), and academic departments is paramount. Patarroyo (talk) 21:46, 25 October 2024 (UTC)