18F-FDG PET Scan for Cardiovascular Disease

Recruiting in Palo Alto (17 mi)

Overseen by Guobao Wang, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, High blood glucose, Claustrophobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a special imaging technique to take pictures of blood flow and sugar use in patients with heart disease, cancer, and brain disorders. This helps doctors see how well blood is flowing and how much sugar different parts of the body are using. This imaging tool is primarily used for diagnosing and evaluating cancer by measuring glucose metabolism.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must fast for at least 6 hours before the scan and avoid strenuous exercise for 24 hours prior.

What evidence supports the effectiveness of the treatment 11C-butanol and 18F-FDG for cardiovascular disease?

Research shows that using 18F-FDG PET scans can help manage patients with severe heart problems by predicting improvements in heart function after certain surgeries. This suggests that 18F-FDG is effective in assessing heart conditions, which might support its use in cardiovascular disease treatment. ^{1 2 3 4 5}

How does the 18F-FDG PET scan treatment for cardiovascular disease differ from other treatments?

The 18F-FDG PET scan is unique because it uses a special imaging technique to detect inflamed areas in the blood vessels, which can help identify cardiovascular disease at a cellular level. Unlike traditional treatments that focus on symptoms or risk factors, this approach provides a detailed view of disease activity and extent, potentially leading to more precise diagnosis and management. ^{6 7 8 9 10}

Research Team

Guobao Wang, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults over 18 who can consent and follow the study schedule. Healthy volunteers must have no cardiovascular or metabolic diseases, while patients with such conditions can join. Exclusions include high blood glucose, weight over 240 kg, pregnancy, recent PET scans in other studies, prisoners, and those unable to consent.

Inclusion Criteria

Ability to understand and willingness to sign an informed consent form

Ability to adhere to the study visit schedule and other protocol requirements

I am 18 years old or older.

Exclusion Criteria

Body weight >240 kg due to limitations of the scanner bed

Self-reported history of dysphoria or anxiety in closed spaces

Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo dynamic 18F-FDG PET/CT and 11C-butanol PET/CT scans to evaluate blood flow and glucose metabolism

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

• 11C-butanol (Radiopharmaceutical)
• 18F-FDG (Radiopharmaceutical)

Trial Overview The trial aims to develop a PET imaging method using a single tracer (18F-FDG) to assess both blood flow and glucose metabolism simultaneously. This could potentially streamline the process of diagnosing various conditions related to heart and metabolic health.

Participant Groups

Group I: Experimental: PET/CT scans Experimental Treatment 2 Interventions

Each subject will undergo a dynamic 18F-FDG PET/CT scan and a dynamic 11C-butanol PET/CT scan on the EXPLORER total-body PET/CT system

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC Davis EXPLORER Molecular Imaging Center Sacramento, CA

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Dr. Bruce J. Tromberg

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Executive Officer since 2019

PhD in Biomedical Engineering from the University of California, Irvine

Dr. Nina F. Schor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

In a randomized trial involving 430 patients with severe left ventricular dysfunction and suspected coronary disease, FDG PET-assisted management did not show a significant overall reduction in cardiac events compared to standard care, with 30% of the PET group experiencing adverse events versus 36% in the standard care group.

However, patients who followed PET recommendations for revascularization showed a significant reduction in cardiac events, particularly in those without recent angiography, indicating that FDG PET may be most beneficial when its recommendations are adhered to.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18-fluorodeoxyglucose positron emission tomography imaging-assisted management of patients with severe left ventricular dysfunction and suspected coronary disease: a randomized, controlled trial (PARR-2). Beanlands, RS., Nichol, G., Huszti, E., et al.[2022]

In a study of 20 patients with severely reduced left ventricular ejection fraction (LVEF) undergoing coronary artery bypass grafting (CABG), preoperative PET scans measuring regional myocardial FDG uptake were able to predict postoperative improvements in heart function, with significant increases in LVEF observed two weeks after surgery.

Patients with higher FDG uptake in the anterior wall showed greater improvements in LVEF post-surgery, indicating that this imaging technique can help identify individuals who are likely to benefit the most from CABG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of positron emission tomography in predicting improved left ventricular ejection fraction after coronary artery bypass grafting among patients with ischemic cardiomyopathy. McFalls, EO., Baldwin, D., Kuskowski, M., et al.[2017]

In a study of 55 patients with left ventricular dysfunction, FDG SPECT successfully identified those who would experience significant improvement in left ventricular ejection fraction (LVEF) after revascularization, with LVEF increasing from 28% to 35% in patients with three or more viable segments.

Patients with fewer than three viable segments on FDG SPECT did not show any improvement in LVEF after revascularization, highlighting the importance of this imaging technique in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of improvement of contractile function in patients with ischemic ventricular dysfunction after revascularization by fluorine-18 fluorodeoxyglucose single-photon emission computed tomography. Bax, JJ., Cornel, JH., Visser, FC., et al.[2019]

Fluorodeoxyglucose (FDG) is a widely used PET imaging agent for cancer detection, but it can produce false positive and false negative results in certain clinical situations.

Research is ongoing to develop new PET tracers, particularly fluorinated compounds, to improve accuracy in cancer imaging and potentially replace FDG in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond FDG: novel PET tracers for cancer imaging. Hicks, RJ.[2021]

In a study involving 430 patients with left ventricular dysfunction, management guided by F-18-fluorodeoxyglucose (FDG) PET imaging showed a trend towards improved quality of life (QOL) compared to standard care, particularly at the 6-month mark.

Patients who adhered to FDG PET recommendations experienced significantly better QOL scores, suggesting that following PET-guided management may enhance treatment outcomes, especially in relation to revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does FDG PET-assisted management of patients with left ventricular dysfunction improve quality of life? A substudy of the PARR-2 trial. Shukla, T., Nichol, G., Wells, G., et al.[2016]

In a study using ApoE-deficient mice, researchers found that increased glucose uptake in atherosclerotic plaques is linked to the activity of hematopoietic stem cells, which express higher levels of the glucose transporter Glut1.

Targeting Glut1 may offer a new therapeutic approach for atherosclerosis, as its deficiency reduced the proliferation of hematopoietic stem cells and slowed the progression of atherosclerosis in the mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disruption of Glut1 in Hematopoietic Stem Cells Prevents Myelopoiesis and Enhanced Glucose Flux in Atheromatous Plaques of ApoE(-/-) Mice. Sarrazy, V., Viaud, M., Westerterp, M., et al.[2023]

In a study of 30 Japanese adults with stable angina pectoris, atorvastatin 20 mg significantly reduced the uptake of (18)F-FDG in atherosclerotic plaques after 6 months, indicating its efficacy in lowering inflammation in arterial lesions.

The reduction in (18)F-FDG uptake was correlated with improvements in lipid profiles and inflammatory markers, suggesting that atorvastatin's mechanism of action involves both lowering LDL cholesterol and reducing inflammation in atherosclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of atorvastatin 5 and 20 mg/d for reducing F-18 fluorodeoxyglucose uptake in atherosclerotic plaques on positron emission tomography/computed tomography: a randomized, investigator-blinded, open-label, 6-month study in Japanese adults scheduled for percutaneous coronary intervention. Ishii, H., Nishio, M., Takahashi, H., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

F-18-fluorodeoxyglucose positron emission tomography imaging-assisted management of patients with severe left ventricular dysfunction and suspected coronary disease: a randomized, controlled trial (PARR-2). [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of positron emission tomography in predicting improved left ventricular ejection fraction after coronary artery bypass grafting among patients with ischemic cardiomyopathy. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Prediction of improvement of contractile function in patients with ischemic ventricular dysfunction after revascularization by fluorine-18 fluorodeoxyglucose single-photon emission computed tomography. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Beyond FDG: novel PET tracers for cancer imaging. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Does FDG PET-assisted management of patients with left ventricular dysfunction improve quality of life? A substudy of the PARR-2 trial. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

(18)F-labelled cardiac PET tracers: selected probes for the molecular imaging of transporters, receptors and proteases. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Disruption of Glut1 in Hematopoietic Stem Cells Prevents Myelopoiesis and Enhanced Glucose Flux in Atheromatous Plaques of ApoE(-/-) Mice. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of atorvastatin 5 and 20 mg/d for reducing F-18 fluorodeoxyglucose uptake in atherosclerotic plaques on positron emission tomography/computed tomography: a randomized, investigator-blinded, open-label, 6-month study in Japanese adults scheduled for percutaneous coronary intervention. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Non-18F-FDG/18F-NaF Radiotracers Proposed for the Diagnosis and Management of Diseases of the Heart and Vasculature. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

[(18)F]Fluorodeoxyglucose PET in Large Vessel Vasculitis. [2016]