Imaging Approaches and Unique RECIST Challenges in Gastric Cancer Clinical Trials
Medical imaging is pivotal in clinical trials for gastric cancer, where precise staging and response evaluation are essential. Imaging technologies like CT, MRI, and PET are integrated into clinical trials, typically using Response Evaluation Criteria in Solid Tumors (RECIST). These criteria standardize tumor measurements, ensuring consistent evaluation of therapeutic efficacy. Imaging Endpoints (IE) excels in implementing these modalities with RECIST criteria clarifications and modifications that optimize clinical trial data for gastric cancer.
Gastric cancer is a significant global health concern and one of the leading oncological causes of death worldwide. Accurate staging is critical for guiding treatment decisions and improving patient outcomes. Advances in diagnostic imaging techniques, including endoscopic ultrasound (EUS), volumetric CT, diffusion-weighted MRI (DWI), and PET innovations such as Ga-FAPI tracers have improved sensitivity in detecting small tumors and metastases while offering precise tumor characterization and staging capabilities.
The RECIST guidelines provide standardized criteria for assessing tumor burden and treatment response. RECIST enables objective measurements of tumor size and progression, ensuring regulatory compliance. In gastric cancer trials, customization of the RECIST read criteria is critical due to primary tumor measurement variability, tumor heterogeneity, and subtle metastasis related qualitative assessments. While these are critical factors for late phase trials, in early-phase trials, a multimodality approach may utilize CT for lesion measurement, MRI (DWI) for tumor cellularity, and PET for metabolic assessments.
FDG-PET is useful for the detection of the node status and determination of best treatment option with a majority of the lesions associated with the FDG-avidity. FAPI PET imaging surpasses FDG PET in many attributes such as detection of the primary tumor, metastatic lesions, and tumor delineation of GI cancers, but it is not an entirely tumor-specific agent and increased uptake has been reported in non-malignant conditions; such requires expert interpretation. FAPI-targeted radiopharmaceuticals are widely used in clinical research with promising results.
A key differentiator of IE’s approach is its ability to deliver program-specific solutions. In gastric cancer trials, customized imaging criteria and workflows are essential for addressing challenges like distinguishing early-stage tumors from inflammatory changes, detecting peritoneal metastases with high sensitivity, and differentiating tumor progression from necrosis.
Imaging Endpoints is the global leader in designing the imaging requirements for clinical trial protocols in gastrointestinal cancer including gastric cancer and has an impeccable inspection record and an exceptional 95% marketing authorization success rate across all clinical trials we have supported.
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