Serial PET MPI in Patients Undergoing Cancer Treatment

Trial Title: Serial PET MPI in Patients Undergoing Cancer Treatment

NCT ID: NCT05913999

Condition: Cancer
Chemotherapeutic Toxicity
Coronary Artery Disease
Coronary Microvascular Disease

Conditions: Official terms:
Coronary Artery Disease
Microvascular Angina

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Summary: This study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (MBF) and perfusion in a prospective sample of VA patients.

Detailed description: Up to 60 patients who will be newly initiating chemotherapy are going to be prospectively evaluated using PET myocardial perfusion imaging (MPI) for chemotherapy-induced cardiotoxicity by quantifying MBF and perfusion. Patients will be grouped into 3 categories: 1. Patients undergoing chemotherapy with anthracycline containing regimen. 2. Patients undergoing chemotherapy with VEGF inhibitor containing regimen. 3. Patients undergoing chemotherapy with immune check point inhibitor containing regimen. Patients will undergo PET MPI at 3 different time points: 1. Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen. 2. PET MPI at the middle of the chemotherapy regimen. 3. PET MPI within 1 month following completion of the chemotherapy regimen. For PET MPI, the investigators will evaluate for abnormalities such as new perfusion defects, decreases in stress myocardial blood flows and decreases in myocardial flow reserves. All study patients will also be analyzed using the following tests: 1. Echocardiogram with strain analysis within +/- 1 week of each PET MPI 2. Serology - high sensitivity troponin, cardiac C-reactive protein (CRP), brain-type natriuretic peptide (BNP), fasting lipid panel, complete metabolic panel, and complete blood count within +/- 1 week of each PET MPI study. 3. 12-lead ECG with each PET MPI study.

Criteria for eligibility:

Study pop:
Patients diagnosed with cancer receiving medical care at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Veterans Affairs oncology patients who will be initiating chemotherapy - Ability to give consent Exclusion Criteria: - Prior chemotherapy - Prior coronary revascularization (percutaneous coronary intervention, coronary artery bypass grafting) - Anyone with previous invasive or CT (computed tomography) angiogram demonstrating any lesion ≥ 50% stenosis - Known cardiomyopathy defined as rest ejection fraction < 50% - History of heart and/or another organ transplant - Pregnancy or breast-feeding status

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: West Los Angeles VA Medical Center

Address:
City: Los Angeles
Zip: 90073
Country: United States

Start date: June 1, 2023

Completion date: May 31, 2026

Lead sponsor:
Agency: University of California, Los Angeles
Agency class: Other

Collaborator:
Agency: VA Greater Los Angeles Healthcare System
Agency class: U.S. Fed

Source: University of California, Los Angeles

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05913999