CancerNCT05913999
Serial PET MPI in Patients Undergoing Cancer Treatment
An observational study of Cancer and Chemotherapeutic Toxicity, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapeutic Toxicity, Coronary Artery Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with cancer receiving medical care at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.
Who may be able to join
- Veterans Affairs oncology patients who will be initiating chemotherapy
- Ability to give consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Los Angeles VA Medical Center
Los Angeles, California, 90073
About this study
Official title: Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION Trial
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.
Read the 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:
- Patients undergoing chemotherapy with anthracycline containing regimen.
- Patients undergoing chemotherapy with VEGF inhibitor containing regimen.
- Patients undergoing chemotherapy with immune check point inhibitor containing regimen.
Patients will undergo PET MPI at 3 different time points:
- Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen.
- PET MPI at the middle of the chemotherapy regimen.
- 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:
- Echocardiogram with strain analysis within +/- 1 week of each PET MPI
- 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.
- 12-lead ECG with each PET MPI study.
- Conditions
- Cancer, Chemotherapeutic Toxicity, Coronary Artery Disease, Coronary Microvascular Disease
- Medical subject headings
- Neoplasms, Coronary Artery Disease, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anthracycline | Patients undergoing chemotherapy with an anthracycline-containing regimen. | |
| VEGF Inhibitor | Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen. | |
| Immune Checkpoint Inhibitor | Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET myocardial perfusion imaging (MPI).
Change from baseline in number of patients with perfusion defects measured as % total perfusion deficit (TPD) of the left ventricular myocardium by PET
Measured: 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)
PET myocardial blood flow (MBF) measurement.
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
Measured: 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)
Secondary outcomes (5)
Transthoracic echocardiography (TTE) global left ventricular systolic function.
Change from baseline in number of patients with global systolic dysfunction measured as % left ventricular ejection fraction by TTE.
Measured: 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)
Transthoracic echocardiography (TTE) focal left ventricular systolic function.
Change from baseline in number of patients with focal systolic dysfunction measured as % left ventricular global longitudinal strain by TTE.
Measured: 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)
Transthoracic echocardiography (TTE) focal left atrial systolic function.
Change from baseline in number of patients with focal systolic dysfunction measured as % left atrial strain by TTE.
Measured: 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)
Electrocardiogram (ECG) findings.
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
Measured: 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)
Metabolic or cardiac function abnormalities as determined by blood work findings
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Responsible party
- Principal investigator, Rene R. Sevag Packard, MD, PhD, University of California, Los Angeles
- Investigators
- Rene Packard, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913999
- Sponsor's protocol ID
- IRBNet 1668650-1
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33433946Herrmann 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.
PubMed 27022039Chang 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.
PubMed 29145954Hader 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.
PubMed 31397169Yeh 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.
PubMed 19520246Murthy 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.
PubMed 29242396Murthy 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.
PubMed 22007073Ziadi 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.
PubMed 21816311
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION Trial
- ClinicalTrials.gov ID
- NCT05913999
- Acronym / sponsor ID
- IRBNet 1668650-1
- Conditions
- Cancer, Chemotherapeutic Toxicity, Coronary Artery Disease, Coronary Microvascular Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- VA Greater Los Angeles Healthcare System
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients undergoing chemotherapy with anthracycline containing regimen.
- Patients undergoing chemotherapy with VEGF inhibitor containing regimen.
- Patients undergoing chemotherapy with immune check point inhibitor containing regimen.
Patients will undergo PET MPI at 3 different time points:
- Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen.
- PET MPI at the middle of the chemotherapy regimen.
- 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:
- Echocardiogram with strain analysis within +/- 1 week of each PET MPI
- 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.
- 12-lead ECG with each PET MPI study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anthracycline | – | –Patients undergoing chemotherapy with an anthracycline-containing regimen. |
| VEGF Inhibitor | – | –Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen. |
| Immune Checkpoint Inhibitor | – | –Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cancer receiving medical care at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.
Key inclusion criteria (2 listed)
- Veterans Affairs oncology patients who will be initiating chemotherapy
- Ability to give consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PET myocardial perfusion imaging (MPI).
Time frame: 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
PET myocardial blood flow (MBF) measurement.
Time frame: 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
5 secondary outcomes
Transthoracic echocardiography (TTE) global left ventricular systolic function.
Time frame: 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)
Transthoracic echocardiography (TTE) focal left ventricular systolic function.
Time frame: 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)
Transthoracic echocardiography (TTE) focal left atrial systolic function.
Time frame: 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)
Electrocardiogram (ECG) findings.
Time frame: 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)
Metabolic or cardiac function abnormalities as determined by blood work findings
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 33433946Siegel 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.
- Background: PubMed 27022039Herrmann 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.
- Background: PubMed 29145954Chang 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.
- Background: PubMed 31397169Hader 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.
- Background: PubMed 19520246Yeh 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.
- Background: PubMed 29242396Murthy 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.
- Background: PubMed 22007073Murthy 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.
- Background: PubMed 21816311Ziadi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rene Packard, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Chemotherapeutic Toxicity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET myocardial perfusion imaging (MPI). (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913999, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.