What side effects are associated with this type of intervention?

The most common side effects of treatments involving 18F-fluorodeoxyglucose (FDG) PET imaging are generally mild and include discomfort at the injection site, such as pain or redness. Some patients may experience a slight metallic taste in the mouth or a warm sensation throughout the body. Rarely, allergic reactions to the tracer can occur, presenting as rash, itching, or difficulty breathing. Overall, FDG PET imaging is considered safe, with serious side effects being uncommon.

What prior FDA approvals exist?

The FDA has approved the use of 18F-fluorodeoxyglucose (FDG) for PET imaging to assess glucose metabolism in various conditions, including cancer detection and monitoring. FDG PET imaging is widely used to evaluate metabolic activity in tissues, helping in the diagnosis and management of diseases such as cancer, where it can detect tumor activity and monitor treatment response. While specific approvals for healthy subjects are not detailed, FDG PET imaging remains a critical tool in both clinical and research settings for understanding metabolic processes.

What other types of research exist?

Promising novel alternatives to 18F-fluorodeoxyglucose (FDG) PET imaging for blood flow and glucose metabolism include fluoroestradiol F-18 PET for estrogen receptor-positive lesions and single-tracer multiparametric PET imaging for simultaneous imaging of blood flow and glucose metabolism. Additionally, prostate-specific radiotracers used in PET/CT or PET/MRI are emerging as valuable tools for specific cancer types.

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18F-FDG PET Scan for Cardiovascular Disease

Q: What is the mechanism of action of this treatment?

18F-fluorodeoxyglucose (FDG) PET imaging works by using FDG, a glucose analog, to measure glucose metabolism in tissues. This imaging technique is particularly useful for identifying areas of high metabolic activity, such as cancer cells. Tracer kinetic modeling in FDG PET allows for the simultaneous assessment of blood flow and glucose metabolism, offering a comprehensive view of tissue function. For healthy subjects, this is important as it aids in the early detection of abnormalities, monitoring metabolic changes, and assessing treatment efficacy non-invasively.

Phase < 1

Recruiting

Led By Guobao Wang, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions from the injection site due to tracer administration or discomfort from lying still during scanning. Anxiety or claustrophobia might occur due to enclosed space of the scanner.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Flow

Secondary study objectives

Metabolism change when using Butanol

Metabolism change when using FDG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: PET/CT scansExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FDG

2017

Completed Phase 4

~750

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

18F-fluorodeoxyglucose (FDG) PET imaging works by using FDG, a glucose analog, to measure glucose metabolism in tissues. This imaging technique is particularly useful for identifying areas of high metabolic activity, such as cancer cells. Tracer kinetic modeling in FDG PET allows for the simultaneous assessment of blood flow and glucose metabolism, offering a comprehensive view of tissue function. For healthy subjects, this is important as it aids in the early detection of abnormalities, monitoring metabolic changes, and assessing treatment efficacy non-invasively.

STatistically Assigned Response Criteria in Solid Tumors (STARCIST).Assessment of 10B concentration in boron neutron capture therapy: potential of image-guided therapy using 18FBPA PET.Absolute quantification of [(11)C]docetaxel kinetics in lung cancer patients using positron emission tomography.