For more information, Google RECIST Minimum Target Lesion Size Number of Measurable Lesions Lesion Measurement Lymph Node Measurement PET RECIST 1.1 ≥ 10mm CT + MR ≥ 15mm Lymph Nodes ≥ 20mm Chest X-Ray Up to 5 total 2 is maximum per organ RECIST 1.0 ≥ 10mm Spiral CT ≥ 20mm Conventional CT + MR Up to 10 total 5 is maximum per organ Bi-dimensional in mm, not cm Bi-dimensional in mm, not cm ≥ 15mm in short axis None May be considered to support CT, for PD and confirmation of CR. Not available Disease Evaluation – Performed by Oncology Staff PD (Progressive Disease) 20% Increase in SOD + min. 5mm increase from Nadir 20% increase in SOD from Nadir Confirmation of CR and PR (Complete Response and Partial Response) Only required if response is primary endpoint and not randomized After at least 28 days Troubleshooting Target lesions should remain the same between studies even if target lesion shrinks below 10mm (15mm for lymph nodes) The longest axis is always measured irrespective of previously measured axis (shortest axis for lymph nodes) New lesions can be added as non-target lesions Non-target lesions are not measured and can be recorded as a group if they are in the same organ CR (complete response) disappearance of all target lesions PR (partial response) 30% decrease in SLD of target lesions PD (progressive disease) 20% increase in SLD of target lesions Selecting Target Lesions 1. Not necessarily the largest – select the best defined and reproducibly measurable 2. Imaging consistency is important. Measure in the same plane of imaging and same phase of contrast 3. Target measurement rules at follow-up, measure where the lesion is largest (doesn’t matter if slice and orientation are different) 4. Lymph Node: only if short axis ≥15mm 5. Bone Mets: Select only if with an identifiable soft tissue component (blastic lesions are non-measurable) 6. Splitting and Merging Lesions: The individual longest diameters of all the resulting lesions shall contribute to the sum of diameters SD (stable disease) small changes that do not meet above criteria SOD Sum of Diameters
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