PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy

Phase 1

Completed

• Conditions: Cancer
• Interventions: Diagnostic Test: PET/CT; Drug: radioactive drug (tracer)

• Registration Number: NCT04538950
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-14
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-04
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Results First Submitted: 2023-07-18
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-07
• Results First Posted: 2023-08-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

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Exclusion Criteria

• Age < 18 years
• Women who are pregnant, or breast-feeding.
• Unable or unwilling to give consent to undergo PET/CT.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Checkpoint Inhibitor (ICI)	PET/CT	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.
Checkpoint Inhibitor (ICI)	radioactive drug (tracer)	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.

Primary Outcome Measures

Name	Time	Method
Microvascular Damage/Endothelial Dysfunction	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States