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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Diagnostic Test

Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.

radioactive drug (tracer)

Drug

A radioactive drug (tracer) is used in the PET scan.

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Sep 4, 2020
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed