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  • Dr. J. James Frost

Imaging in Therapeutic Trials | Late Phase

Updated: May 10

Molecular imaging in therapeutic trials, especially late phase, uses imaging to guide treatment with increasingly precise evaluations of lymphoma, prostate cancer, neoplasms, cardiac diseases, dementia and other metastatic diseases.


BioMolecular Imaging has extensive, decades-long experience in anatomic and molecular imaging as applied to the conduct of therapeutic trials and the determination of drug targeting and efficacy. This spans most all imaging modalities, organ systems, and therapeutic areas.



Trial design, data analysis, and expert image reads are areas of expertise.


Late phase trials often combine a therapeutic target imaging agent with the therapeutic drug as an approach to improve patient outcomes. This powerful strategy can be extended to a commercializable imaging-therapeutic combination to stratify patients for treatment and/or to monitor patient response.


Some goals require labeling the therapeutic drug, but more often the therapeutic and imaging agent are different molecular entities, consistent with the different requirements for imaging and treatment.


“We can help your company design, obtain approval, and carry out these trials. Careful planning and continuity with earlier phase I and II trial results is key.” - Dr. J. James Frost, Founder of BioMolecular Imaging.


More traditional late phase studies utilize conventional anatomic imaging modalities, such as CT and MR imaging. BioMolecular Imaging can assist your company in identifying the most appropriate modality, trial design and analytical approach for image analysis.


Phase III/IV studies require the development of image read rules and radiologist/nuclear medicine physician training when a new agent is introduced into clinical use. This is especially true in the current climate with the advent of new Food and Drug Administration approval criteria. Various approaches to reader training, including those using in-person and online methods, are relevant. Specialized image analysis workstations and software applications are increasingly used together with imaging probe-specific reader guidelines.

About BioMolecular Imaging


BioMolecular Imaging (BMI Consultants) is a molecular imaging and clinical trial consultancy owned and operated by Dr. J. James Frost M.D./Ph.D out of Baltimore Maryland. BMI has been involved with clinical, therapeutic & diagnostic imaging focused on Oncology, Brain, Biomarkers, Cardiology and Central Image Interpretations for over 20 years.


To learn more about BioMolecular Imaging, please visit https://www.BioMolecularImaging.com or connect with:



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BioMolecular Imaging is a registered trademark of BioMolecular Imaging D.B.A. BMI Consultants

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