Pacific Northwest Clinical Trial Course:

Imaging Integration in Clinical Trial Design

Questions for Development
1. What is the biological imperative for the tumor of interest for my study? (e.g. perfusion,
hypoxia, metabolism, cellular density, immune response)?
a. Is there an in vivo quantitative imaging modality that can interrogate this parameter?
2. What is the standard of care imaging process for each portion of the trial?
a. Diagnosis
i. Can additional imaging exams be added?
ii. Is there a quantitative component that can be added to standard of care
imaging?
iii. Is there a novel imaging component that can be added to the protocol for
diagnosis?
iv. Is there an imaging QA, analytic, or correlative question that can be added to
the trial at diagnosis?
b. Therapy
i. What imaging is obtained via standard of care (IGRT/response imaging/postsurgical imaging/anatomic pathology)?
ii. Can pathology/laboratory correlation be performed?
iii. Can images be registered to dose and/or diagnostic imaging?
iv. Can a novel or quantitative imaging component be added?
v. Can imaging kinetics during therapy be obtained (response velocity, early
response imaging, etc.)?
c. Post-therapy response
i. What is my primary trial end point? Does it have an imaging component?
ii. What criteria will I use (RECIST, PERCIST, WHO, Immuno)?
iii. Can I add a quantitative imaging technique to response imaging?
iv. Can I correlate this imaging with dose/kinetics/pre-therapy parameters?
d. Extended surveillance imaging
i. Surveillance imaging will use what modality, with what frequency?
ii. Can I add novel/quantitative imaging to surveillance? With what frequency?
iii. Can I image normal tissue injury in surveillance? If so, how frequently, and can I
correlate with dose/therapy spatially?
iv. Can I map failure geometrically and dosimetrically to pre-/midtherapy imaging?

3. Quality assurance
a. Will multiple scanner/devices be used? How will these be QAd?
b. Will multiple sites enroll? Will imaging be credentialed?
i. How will images from all sites be collected/analyzed?
c. Can I standardize or QA the following:
i. Target delineation?
ii. IGRT?
4. Additional questions:
a. Who is my identified DI collaborator?
b. Who is my identified imaging physics collaborator?
c. Who is my identified therapy physics collaborator?
i. Can I add cumulative dose information during treatment?
ii. Is there a technical parameters? (4DCT, adaptive therapy) which may be added
as a feature?
d. Who is my identified (bio)statistician?
i. Can I add a novel statistical design?
ii. Are dose/volume/response/ modeling spatial analytics available?
e. Who is my identified data/informatics collaborator?
i. How will I collect/manage/correlate imaging data with:
1. Pathology
2. Functional assessments
3. PROs
4. Physician-rated toxicity
5. omics
6. circulating tumor cells/liquid biopsy/biospecimens