Serial PET MPI in Patients Undergoing Cancer Treatment

NCT ID: NCT05913999

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Cancer Chemotherapeutic Toxicity Coronary Artery Disease Coronary Microvascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anthracycline

Patients undergoing chemotherapy with an anthracycline-containing regimen.

No interventions assigned to this group

VEGF Inhibitor

Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen.

No interventions assigned to this group

Immune Checkpoint Inhibitor

Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Greater Los Angeles Healthcare System

FED

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Rene R. Sevag Packard, MD, PhD

Assistant Professor-in-Residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rene Packard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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West Los Angeles VA Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

Reference Type BACKGROUND
PMID: 33433946 (View on PubMed)

Herrmann J, Yang EH, Iliescu CA, Cilingiroglu M, Charitakis K, Hakeem A, Toutouzas K, Leesar MA, Grines CL, Marmagkiolis K. Vascular Toxicities of Cancer Therapies: The Old and the New--An Evolving Avenue. Circulation. 2016 Mar 29;133(13):1272-89. doi: 10.1161/CIRCULATIONAHA.115.018347.

Reference Type BACKGROUND
PMID: 27022039 (View on PubMed)

Chang HM, Moudgil R, Scarabelli T, Okwuosa TM, Yeh ETH. Cardiovascular Complications of Cancer Therapy: Best Practices in Diagnosis, Prevention, and Management: Part 1. J Am Coll Cardiol. 2017 Nov 14;70(20):2536-2551. doi: 10.1016/j.jacc.2017.09.1096.

Reference Type BACKGROUND
PMID: 29145954 (View on PubMed)

Hader SN, Zinkevich N, Norwood Toro LE, Kriegel AJ, Kong A, Freed JK, Gutterman DD, Beyer AM. Detrimental effects of chemotherapy on human coronary microvascular function. Am J Physiol Heart Circ Physiol. 2019 Oct 1;317(4):H705-H710. doi: 10.1152/ajpheart.00370.2019. Epub 2019 Aug 9.

Reference Type BACKGROUND
PMID: 31397169 (View on PubMed)

Yeh ET, Bickford CL. Cardiovascular complications of cancer therapy: incidence, pathogenesis, diagnosis, and management. J Am Coll Cardiol. 2009 Jun 16;53(24):2231-47. doi: 10.1016/j.jacc.2009.02.050.

Reference Type BACKGROUND
PMID: 19520246 (View on PubMed)

Murthy VL, Bateman TM, Beanlands RS, Berman DS, Borges-Neto S, Chareonthaitawee P, Cerqueira MD, deKemp RA, DePuey EG, Dilsizian V, Dorbala S, Ficaro EP, Garcia EV, Gewirtz H, Heller GV, Lewin HC, Malhotra S, Mann A, Ruddy TD, Schindler TH, Schwartz RG, Slomka PJ, Soman P, Di Carli MF; SNMMI Cardiovascular Council Board of Directors; ASNC Board of Directors. Clinical Quantification of Myocardial Blood Flow Using PET: Joint Position Paper of the SNMMI Cardiovascular Council and the ASNC. J Nucl Med. 2018 Feb;59(2):273-293. doi: 10.2967/jnumed.117.201368. Epub 2017 Dec 14. No abstract available.

Reference Type BACKGROUND
PMID: 29242396 (View on PubMed)

Murthy VL, Naya M, Foster CR, Hainer J, Gaber M, Di Carli G, Blankstein R, Dorbala S, Sitek A, Pencina MJ, Di Carli MF. Improved cardiac risk assessment with noninvasive measures of coronary flow reserve. Circulation. 2011 Nov 15;124(20):2215-24. doi: 10.1161/CIRCULATIONAHA.111.050427. Epub 2011 Oct 17.

Reference Type BACKGROUND
PMID: 22007073 (View on PubMed)

Ziadi MC, Dekemp RA, Williams KA, Guo A, Chow BJ, Renaud JM, Ruddy TD, Sarveswaran N, Tee RE, Beanlands RS. Impaired myocardial flow reserve on rubidium-82 positron emission tomography imaging predicts adverse outcomes in patients assessed for myocardial ischemia. J Am Coll Cardiol. 2011 Aug 9;58(7):740-8. doi: 10.1016/j.jacc.2011.01.065.

Reference Type BACKGROUND
PMID: 21816311 (View on PubMed)

Other Identifiers

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IRBNet 1668650-1

Identifier Type: -

Identifier Source: org_study_id

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