PAREXEL
Topic 1 | Section 4.3.2

Change 14: Lesions that Split or Coalesce

RECIST 1.0:

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

RECIST 1.1:

  • When non-nodal lesions ‘fragment’, the longest diameters of the fragmented portions should be added together to calculate the target lesion sum
  • Similarly, as lesions coalesce, a plane between them may be maintained that would aid in obtaining maximal diameter measurements of each individual lesion. If the lesions have truly coalesced such that they are no longer separable, the vector of the longest diameter in this instance should be the maximal longest diameter for the ‘coalesced lesion’