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The Pivotal Role of Imaging in Advancing Colorectal Cancer Clinical Trials

Colorectal cancer (CRC) is the third most frequent cancer diagnosed in the world, and the second most frequent cause of death related to cancer. Imaging has a critical role in diagnosis, determining stage of the disease, selecting treatment strategies, and monitoring response to treatment. Over the past decade, Imaging Endpoints has worked with sponsors to support research advances that have improved early diagnosis and disease outcome through effective treatment options including systemic and locoregional therapy. These breakthroughs underscore the critical role imaging plays in advancing CRC clinical trials and patient outcomes.

CRC affects the large intestine, including the colon, rectum, and anal canal. Screening is recommended for individuals aged 45 to 75 and can be done through stool tests or imaging methods such as CT colonography, flexible sigmoidoscopy, and colonoscopy.  The current recommended imaging required for CRC diagnosis and treatment monitoring remains the anatomical imaging, including CT and MRI. Over the last 20 years, imaging in CRC clinical trials has evolved to include advanced functional techniques (e.g., DCE, DWI) and metabolic approaches (e.g., PET).

Imaging Endpoints (IE) is leading the industry in designing customized imaging solutions for each unique CRC clinical trial. With a proven track record of optimizing trial outcomes, IE specializes in tailoring imaging charters and implementing advanced imaging strategies to meet study goals.

RECIST criteria is the standard Imaging assessment criteria that is used for CRC clinical trials. However, there are some challenges for accurately measuring intramural tumors, peritoneal metastases, and cecal tumors due to the complex anatomy. Other limitations may be the assessment of tumor morphology and heterogeneity. Response patterns such as pseudoprogression due to novel therapies (e.g. immunotherapy) require modifications to RECIST criteria and deployment of iRECIST criteria.

CT is widely used to identify metastases and stage the disease, while MRI is preferred for assessing liver metastases esp. in fatty liver patients and staging rectal cancer involving surrounding soft tissues. Imaging Endpoints addresses challenges such as tumor heterogeneity, intramural assessments, and novel therapy response criteria by integrating techniques such as DCE MRI for tumor vascularity, perfusion CT/MRI for blood flow analysis, DWI for tumor cellularity, and PET/CT for detecting small metastases and evaluating tumor metabolism.

Imaging Endpoints is the global leader in designing the imaging requirements for clinical trial protocols in Oncology, with vast experience and success in CRC. With a strong track record of improving trial outcomes by implementing the best strategy, and optimizing the imaging charter and assessment criteria, IE is setting new records in regulatory approvals.

Imaging Endpoints is dedicated to advancing the field of colorectal cancer clinical trials through innovative imaging solutions and expert insights. To arrange a conversation with our medical and scientific experts.

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