PAREXEL
Topic 1 | Section 3.1.3

Change 4: Bone Lesion Measurability

RECIST 1.0:

  • Lesions considered to be truly non-measurable include the following: bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging techniques, and cystic lesions.

RECIST 1.1:

  • Lytic bone lesions, with an identifiable soft tissue component, evaluated by CT or MRI, can be considered as measurable lesions if the soft tissue component otherwise meets the definition of measurability previously described
  • Blastic bone lesions are non-measurable