Clincosm LogoSign in Get a demo

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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04538950
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
21.1
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/CT
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Actual Study Start Date :
Aug 14, 2020
Actual Primary Completion Date :
May 19, 2022
Actual Study Completion Date :
May 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Checkpoint Inhibitor (ICI)

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
Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning. A radioactive drug (tracer) is used in the PET scan.

Outcome Measures

Primary Outcome Measures

  1. Microvascular damage/endothelial dysfunction [6 weeks]

    Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: John Bois, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
John P. Bois, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04538950
Other Study ID Numbers:
  • 19-009189
First Posted:
Sep 4, 2020
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 5, 2022