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Imaging biomarker roadmap for cancer studies.

James P B O'Connor¹, Eric O Aboagye², Judith E Adams³

¹CRUK and EPSRC Cancer Imaging Centre in Cambridge and Manchester, University of Manchester, Manchester, UK.

Nature Reviews. Clinical Oncology

|October 12, 2016

Summary

Developing new imaging biomarkers (IBs) for cancer requires a tailored roadmap. This consensus outlines 14 recommendations to accelerate the clinical translation of IBs through validation and qualification.

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Area of Science:

Oncology
Medical Imaging
Biomarker Development

Background:

Imaging biomarkers (IBs) are crucial for cancer patient management and research, distinct from biospecimen biomarkers.
Current use includes TNM staging and response assessment; advanced imaging like CT, MRI, and PET are vital in research.
Bridging translational gaps for new IBs requires rigorous validation and qualification for clinical utility.

Framework:

A tailored roadmap is essential for imaging biomarker development, differing from biospecimen biomarker pathways.
Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) convened experts to address IB validation challenges.
Fourteen key recommendations focus on accelerating clinical translation of IBs.

Implementation:

Emphasizes parallel tracks for technical (assay), biological/clinical validation, and cost-effectiveness assessment.
Highlights the need for standardization and accreditation systems for IBs.
Stresses continuous evaluation of IB precision and proposes an alternative framework for biological/clinical validation.

Implications:

Multicenter studies are essential for qualifying IBs for widespread clinical adoption.
The recommendations aim to streamline the process of bringing novel imaging biomarkers into routine cancer care.
Facilitates the development of more effective diagnostic and prognostic tools in oncology.