PAREXEL
Topic 1 | Section 4.3.2

Change 13: Too Small to Measure

RECIST 1.0:

  • No specific recommendations; in line with PAREXEL’s modification

RECIST 1.1:

  • All target lesions (nodal and non-nodal) recorded at baseline should have their actual measurements recorded at each subsequent evaluation, even when very small (e.g. 2 mm)
  • However, if target lesions or lymph nodes become so faint on CT scan that the radiologist may not feel comfortable assigning an exact measure and may report them as being ‘too small to measure’ and a default value of 5 mm should be assigned