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Tumor Assessment Using RECIST 1.1 and mRECIST: Quick Reference Sheet

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Understanding Novel Response Patterns of Immunotherapies

Immunotherapies display novel response patterns that affect the design of imaging based studies and the subsequent evaluation of imaging data. Applying traditional chemotherapy-based response assumptions to immunotherapy trials can result in inaccurate interpretation of response, premature therapy termination, and unnecessary removal of subjects from a trial. Our unique solutions for medical image analysis and management and iBiopsy® for imaging phenotyping, together with our global team of experts, are advancing the development of new drugs and diagnostic tools to monitor disease and assess response to therapy.

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FDA Inspection

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Scientific publications

Mis-selection of non-malignant lesions as target lesions: Misclassification of RECIST 1.1 and Early Termination of Promising Drugs?

Antoine Iannessi [1], Hubert Beaumont [1], Yan Liu [1], Anne Sophie Bertrand [2] - Affiliations: [1] Median Technologies, Valbonne, France, [2] Polyclinique Les Fleurs, 83190 Ollioules, France

Poster presented at the ESMO 2020 Virtual Congress | September 17, 2020 |Poster Display Session 1936P

For tumor response assessment in oncology trials with radiology, the baseline (BL) evaluation is critical as the selection of target lesions (TL) determines the quality of follow-up. The RECIST workgroup provided a method and recommendations for: 1) selecting TL and non-target lesions (NTL) for reporting disease evolution, 2) choosing up to 5 targets, with a maximum of two per organs. In the practice, the selection of TL is subjective; non-malignant (NM) lesions might be mistaken as TLs. The objectives of the study are 1) to analyze the impact of selecting non-malignant lesions as target lesions at baseline, and 2) to present recommendations to mitigate risks in clinical trials.

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