THE MULTIFACETED IMAGING VALUE CHAIN APPLIED TO CLINICAL TRIALS & (MULTIPLE) ENDPOINTS

Multi Faceted Imaging – i.e. generating images with different faces, weightings, and contrasts (mainly by MRI) – has revolutionized medical diagnostics!

Complex pathologies can now be visualized and identified with much greater precision and accuracy (precision medicine) than possible thus far when relying on traditional imaging technologies.

Imaging phenotypes may be now applied to osteoarthritis (OA) research, to stratify patient subcohorts with various rates of progression – and with potentially differential response to various disease modifying OA drugs (DMOADs).

This is what our current whitepaper, just published in Skeletal Radiology is all about: (Authors: Felix Eckstein, Ali Mobasheri, Mikael Boesen)

HERE YOU MAY READ:

• About imaging phenotypes, ordinary phenotypes, morphotypes, endotypes, and theratypes (treatment response patient strata), defined in Table 1.
• About MRI contrast mechanism and best practice choices in osteoarthritis imaging – with and without iv contrast medium, and what these contrasts specifically relate to (also covered recently in https://pubmed.ncbi.nlm.nih.gov/39183946/
• About how patient selection for a clinical trial & the specific MRI acquisition protocol should be tailored to the specific investigational medical product (IMP – the DMOAD) with its unique mechanism of action (MOA)
• About how the image analysis techniques applied (which must be thoroughly validated and regulatory compliant) should precisely match the (multi-faceted) MRI acquisition protocol
• About how the study (imaging) endpoints used must be supported by appropriate patient selection, image acquisition, and the analytic methods applied (also covered recently in https://pubmed.ncbi.nlm.nih.gov/38331162/

As one can see, the ONE FACE / CONTRAST fits ALL approach is “history” in osteoarthritis research.

• Eventually we describe which (imaging) study endpoints to choose, and how various endpoints & outcomes may be combined in a statistically sound manner.

This is covered in greater depth in another recently published concept paper

This publication is part of a Special Issue of Osteoarthritis Imaging (OSTIMA) on the topic of imaging & pain, and was presented in the International Workshop of Osteoarthritis Imaging (IWOAI) of the ISOAI in Marrakesch, Morocco in July 2024. (Authors: Felix Eckstein, Tanja Stamm & Jamie Collins)

Amongst providing a conceptional framework on imaging endpoints, it is about definitions, the subject matter and the meaning of terms, such as:

Assessment / Score / Grade / Measure / Metric / Domain
Biomarker / Endpoint / Outcome / Surrogate (endpoint)

Single univariable & multivariable endpoints
Aggregate (univariable) endpoints
Multi-component, single & multi-domain endpoints
Composite, single & multi-domain endpoints

And further it deals with the statistical implications of their usage and application in osteoarthritis research.

Enjoy, delve into, and send your questions / comments / and points for discussion, because this is what these whitepapers are all about.