PAREXEL
Topic 1 | Section 4.3.5

Change 16: PET

RECIST 1.0:

  • No specific recommendations.

RECIST 1.1:

  • It is sometimes reasonable to incorporate FDG-PET to complement CT scanning in assessment of progression:
    • Negative PET at baseline, with a positive PET at follow-up is PD based on a new lesion.
    • No PET at baseline and a positive PET at follow-up:
      • If the positive PET at follow-up corresponds to a new site of disease on CT, this is PD.
      • If the positive PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up CT scans are needed to determine if there is truly progression occurring at that site (if so, the date of PD will be the date of the initial abnormal PET scan).
      • If the positive PET at follow-up corresponds to a pre-existing site of disease on CT that is not progressing on the basis of the anatomic images, this is not PD.