18F-FDG PET Scan for Cardiovascular Disease

Overseen By Guobao Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, High blood glucose, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using PET scans to better understand blood flow and sugar use in the body, potentially aiding in the diagnosis and treatment of heart and related diseases. It employs a special tracer, 18F-FDG (a type of radiotracer), to observe blood flow and sugar usage in tissues. Individuals with heart or related health issues, such as heart disease or diabetes, and those without these conditions, may qualify if they can fast for six hours and remain still for about an hour during the scan. As an Early Phase 1 trial, this research aims to understand how this new approach functions in people, offering participants a chance to contribute to groundbreaking medical advancements.

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 prior data suggests that this imaging technique is safe for cardiovascular disease?

Research has shown that 18F-FDG, a substance used in PET scans, is generally safe. It has been used to assess heart conditions and typically exits the body within a few days. Some individuals might experience minor side effects, such as redness or swelling at the injection site, but these usually resolve quickly.

Early studies suggest that 11C-butanol can effectively measure blood flow in the body. However, it is important to note that butanol can affect the brain and nervous system, similar to alcohol, potentially altering mood or alertness. The effects during a PET scan are not yet fully understood.

As this trial is in an early stage, the primary goal is to assess safety and dosage. While initial data appears promising, further research is necessary to confirm these findings. Participants should consider these factors when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FDG PET scan for cardiovascular disease because it offers a new way to visualize metabolic activity and blood flow in the heart. Unlike current imaging methods that mainly assess anatomical structures, this approach uses 18F-FDG and 11C-butanol to provide dynamic, functional insights by highlighting areas of inflammation and perfusion. This can potentially lead to earlier and more precise detection of cardiovascular issues, allowing for more targeted treatment strategies. The use of the EXPLORER total-body PET/CT system further enhances this by capturing comprehensive images of the entire body in a single scan, which is a breakthrough in medical imaging.

What evidence suggests that this imaging technique is effective for cardiovascular disease?

In this trial, participants will undergo both 18F-FDG and 11C-butanol PET/CT scans to assess cardiovascular health. Research has shown that 18F-FDG helps identify heart-related issues, such as unstable plaque in arteries and inflammation of blood vessels. It detects changes in blood flow and sugar use in the body, which are crucial for understanding heart health. Studies have found that higher levels of 18F-FDG in arteries can predict future heart problems, such as heart attacks.

For 11C-butanol, research suggests it measures blood flow throughout the body. This helps doctors evaluate heart function and may be useful for assessing overall heart health. Both imaging agents offer promising ways to examine heart function and detect potential problems early. ^{3 6 7 8 9}

Who Is on the Research Team?

Guobao Wang, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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

No strenuous exercise for 24 hours prior to being scanned

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 11C-butanol
• 18F-FDG

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Published Research Related to This Trial

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]

[(18)F]fluorodeoxyglucose (FDG) PET is a highly effective noninvasive imaging technique for assessing the activity and extent of giant cell arteritis and Takayasu's arteritis, identifying more affected vascular regions than MRI.

The method provides high specificity in distinguishing arteritis from atherosclerosis through visual grading of vascular FDG uptake, especially when performed during the active inflammatory phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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 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]

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]

(18)F-labelled radiopharmaceuticals, particularly the glucose analogue [(18)F]FDG, are effective molecular imaging probes for non-invasively examining cardiovascular diseases using positron emission tomography (PET).

The review highlights both established and developing (18)F-labelled PET tracers that target specific proteins involved in cardiovascular conditions, such as receptors and transporters, which could enhance our understanding of these diseases at a cellular level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labelled cardiac PET tracers: selected probes for the molecular imaging of transporters, receptors and proteases. Kopka, K., Schober, O., Wagner, S.[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]

18F-FDG and 18F-NaF are commonly used PET tracers but have limitations in effectively imaging heart diseases.

Recent studies suggest that alternative radiotracers may offer better identification and monitoring of cardiovascular diseases, indicating a need for further research to establish their clinical value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-18F-FDG/18F-NaF Radiotracers Proposed for the Diagnosis and Management of Diseases of the Heart and Vasculature. Hancin, EC., Raynor, WY., Borja, AJ., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7854759/

11C-acetate PET: a powerful tool to analyze metabolic and ... C-acetate PET: a powerful tool to analyze metabolic and functional changes in the heart related to alcohol consumption.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10626376/

Total-Body Perfusion Imaging with [11C]-Butanol - PMC This study demonstrated that [ 11 C]-butanol can be used for quantitative assessment of perfusion through total-body PET, with potential application for ...

3. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-021-02040-2

Association of alcohol consumption with morbidity and ... Light-to-moderate alcohol consumption has been reported to be cardio-protective among apparently healthy individuals.

4. researchgate.net researchgate.net/publication/373580965_Total-Body_Perfusion_Imaging_with_11C-Butanol

Total-Body Perfusion Imaging with [11C]-Butanol Conclusion: This pilot study demonstrates the ability to obtain reproducible measurements of total-body perfusion using [11C]-butanol. The ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acs.chemrev.2c00398

Radiosynthesis, Preclinical, and Clinical Positron Emission ... (14) Butanol has similar effects as ethanol when ingested and is considered a central nervous system (CNS) depressant. Carbon-11 alcohols have ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/11/1831

Total-Body Perfusion Imaging with [ 11 C]-Butanol This pilot study demonstrates the ability to obtain reproducible measurements of total-body perfusion using [ 11 C]-butanol.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37652544/

Total-Body Perfusion Imaging with [11C]-Butanol - PubMed This pilot study demonstrates the ability to obtain reproducible measurements of total-body perfusion using [ 11 C]-butanol.

8. go.drugbank.com go.drugbank.com/indications/DBCOND0055730/clinical_trials/DB02145?phase=1&status=recruiting

Cardiovascular Disorders Recruiting Phase 1 Trials for ... Cardiovascular Disorders Recruiting Phase 1 Trials for Butyl alcohol (DB02145) ; NCT06014515. Single-tracer Multiparametric PET Imaging, Basic Science.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8924109/

Alcohol Consumption and Cardiovascular Disease Risk A clear link between excessive alcohol consumption and cardiovascular disease (CVD) has been established, but no consensus exists on the effects of moderate ...