Radiological imaging has an important role in evaluating CLL and validating therapeutic agent response assessment outcomes in clinical trials.
- The IWCLL guidelines specifies CT scans of the abdomen, pelvis and thorax as desirable. These guidelines also recommend that CT scans in a clinical trial setting should be performed to validate CR and PR.
- We recommend that the neck should be included in order to fully visualize cervical lymph nodes.
When CR is an important clinical trial endpoint:
- A CT scan will visualize any intra-abdominal and other visceral sites of disease, out of reach by physical examination, in order to verify that the entire disease burden has normalized to Complete Remission.
If Progression Free Survival (PFS) is an important endpoint:
- Sponsors may also consider implementing regularly scheduled CT scans in order to refine the earliest date of progression and better differentiate between treatment arms as there may be radiographic progression of nodal or extranodal lesions which is not assessable by physical examination.
With the exception of patients with suspected Richter Transformation, FDG-PET is not useful in CLL. Additionally, MRI and other imaging techniques are generally not useful or recommended in CLL.
The radiological assessment of disease sites should be applied in the same manner as in the 2007 IWG-NHL guidelines including extranodal lesions (nodules in solid organs), even though the 2008 IWCLL guidelines do not explicitly account for these sites. This intent has been confirmed in discussion with some of the original authors of the 2008 IWCLL publication.