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

NCT04538950 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 19-009189
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Microvascular Damage/Endothelial Dysfunction

  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.

  6 weeks

Study Arms (1)

Checkpoint Inhibitor (ICI)

OTHER

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.

Diagnostic Test: PET/CT; Drug: radioactive drug (tracer)

Interventions

PET/CT DIAGNOSTIC_TEST

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

Checkpoint Inhibitor (ICI)

radioactive drug (tracer) DRUG

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

Checkpoint Inhibitor (ICI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms

Interventions

Positron Emission Tomography Computed Tomography; Radiopharmaceuticals; Product Labeling

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals; Product Packaging; Industry; Technology, Industry, and Agriculture

Results Point of Contact

• Title: John P. Bois, M.D.
• Organization: Mayo Clinic

Bois.John@mayo.edu

507 284-4072

Study Officials

• John Bois, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: August 14, 2020
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: September 13, 2023
• Results First Posted: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)