Serial PET MPI in Patients Undergoing Cancer Treatment

• Conditions: Cancer; Chemotherapeutic Toxicity; Coronary Artery Disease; Coronary Microvascular Disease

• Registration Number: NCT05913999
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-17
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PET myocardial blood flow (MBF) measurement.	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with myocardial blood flow abnormalities measured as stress myocardial blood flow (SMBF) values \< 2 mL/min/g of left ventricular myocardium by PET
PET myocardial perfusion imaging (MPI).	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with perfusion defects measured as % total perfusion deficit (TPD) of the left ventricular myocardium by PET

Secondary Outcome Measures

Name	Time	Method
Transthoracic echocardiography (TTE) focal left atrial systolic function.	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with focal systolic dysfunction measured as % left atrial strain by TTE.
Transthoracic echocardiography (TTE) focal left ventricular systolic function.	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with focal systolic dysfunction measured as % left ventricular global longitudinal strain by TTE.
Metabolic or cardiac function abnormalities as determined by blood work findings	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with changes in the values of serological tests indicative of metabolic or cardiac function abnormalities including one or more of the following: * high sensitivity troponin (ng/L); * cardiac C-reactive protein (mg/L); * brain-type natriuretic peptide (pg/mL); * fasting lipid panel: total cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), triglycerides (mg/dL); * complete metabolic panel: total protein (g/dL), albumin (g/dL), total bilirubin (mg/dL), direct bilirubin (mg/dL), aspartate aminotransferase (IU/L), alanine transaminase (IU/L), alkaline phosphatase (IU/L), sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), bicarbonate (mmol/L), blood urea nitrogen (mg/dL), creatinine (mg/dL), glucose (mg/dL); * complete blood count: white blood cell count (k/uL), hemoglobin (g/dL), hematocrit (%), platelet (k/uL)
Transthoracic echocardiography (TTE) global left ventricular systolic function.	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with global systolic dysfunction measured as % left ventricular ejection fraction by TTE.
Electrocardiogram (ECG) findings.	Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)	Change from baseline in number of patients with any of the following ECG changes: * new T-wave inversions; * new ST-segment deviations \>/= 1mm; * new left bundle branch block

Trial Locations

Locations (1)

West Los Angeles VA Medical Center; 🇺🇸 Los Angeles, California, United States