PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Overview
- Phase
- Phase 1
- Intervention
- PET/CT
- Conditions
- Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Microvascular Damage/Endothelial Dysfunction
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.
Investigators
John P. Bois, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •First time administration of ICI
- •Willing and able to return in 4-6 weeks for follow-up study
- •Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)
Exclusion Criteria
- •Age \< 18 years
- •Women who are pregnant, or breast-feeding.
- •Unable or unwilling to give consent to undergo PET/CT.
Arms & Interventions
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
Intervention: PET/CT
Checkpoint Inhibitor (ICI)
Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only.
Intervention: radioactive drug (tracer)
Outcomes
Primary Outcomes
Microvascular Damage/Endothelial Dysfunction
Time Frame: 6 weeks
Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan. PET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis.