Clinical trial · Interventional
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
NCT04538950CI-TRIAL-00069527completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT | Diagnostic Test | — | UNRESOLVED |
| radioactive drug (tracer) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Checkpoint Inhibitor (ICI)
- description
- 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.
- interventionNames
- Diagnostic Test: PET/CT
- Drug: radioactive drug (tracer)
Primary outcomes (1)
- measure
- Microvascular Damage/Endothelial Dysfunction
- timeFrame
- 6 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.