NCT04538950

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

Completed Phase 1, PHASE2 Results posted Last updated 13 September 2023

What this trial tests

Phase 1, PHASE2 trial testing PET/CT in Cancer in 6 participants. Completed in 19 May 2022.

Timeline

14 August 2020

Primary endpoint
19 May 2022

19 May 2022

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	14 August 2020
Primary completion	19 May 2022
Estimated completion	19 May 2022
Sites	1 location across United States

Drugs / interventions tested

• PET/CT
• radioactive drug (tracer) — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Microvascular Damage/Endothelial Dysfunction Primary · 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.

Group	Value	95% CI
Checkpoint Inhibitor (ICI)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 6 weeks on all participants.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Checkpoint Inhibitor (ICI)

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (5 terms — click to expand)

Reaction	System	Checkpoint Inhibitor (ICI)
Mild atrial fibrillation	Cardiac disorders	—
Moderate Sepsis	Infections and infestations	—
Mild vomiting	Gastrointestinal disorders	—
Moderate chest pain	Cardiac disorders	—
Mild Ileus	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04538950 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.