ver RECIST 1.1 - Perceptive Informatics
PAREXEL
Topic 1 | Section 3.1.1

Change 1: Measurability of Tumors at Baseline

RECIST 1.0:

  • At baseline, measurable tumor lesions will be categorized as follows:
    • Lesions that can be accurately measured in at least one dimension [longest diameter to be recorded] as ≥ 20 mm with conventional techniques or
    • ≥ 10 mm with spiral CT scan or nonmeasurable

RECIST 1.1:

  • Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
    • 10mm by CT scan (irrespective of scanner type) and MRI (no less than double the slice thickness and a minimum of 10mm)
    • 10mm caliper measurement by clinical exam (when superficial)
    • 20mm by chest X-ray (if clearly defined and surrounded by aerated lung)