Imaging biomarker roadmap for cancer studies

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.