Single-tracer Multiparametric PET Imaging

NCT ID: NCT06014515

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2033-08-31

Brief Summary

The overarching goal of this project is to develop and evaluate a single-tracer multiparametric positron emission tomography (PET) imaging solution for simultaneous imaging of blood flow and glucose metabolism using 18F-fluorodeoxyglucose (FDG) alone. The investigators working hypothesis is that quantitative blood flow can be extracted from dynamic 18F-FDG PET data by use of tracer kinetic modeling, in addition to glucose metabolism that 18F-FDG is conventionally used for.

Detailed Description

Blood flow and glucose metabolism are two basic but vital physiological processes that are often dysregulated in major diseases. The phenomenon of flow-metabolism mismatch (or coupling) is of broad clinical and research significance. For example, (a) in ischemic cardiomyopathy, which affects several million people in the United States, myocardial flow-metabolism mismatch is clinically used for assessing tissue viability to select patients for surgical revascularization. Decreased blood flow but maintained glucose metabolism suggests the myocytes are still alive (while hibernating) and thus can benefit from revascularization; (b) In oncology, altered blood flow and glucose metabolism are closely related to two hallmarks of cancer - angiogenesis and increased cell metabolism. High metabolism-to-flow ratio may indicate cancer cells are resistant to therapy; (c) In the normal brain, cerebral blood flow and glucose metabolism are often coupled with each other but may become uncoupled in neurodegenerative diseases including Alzheimer's disease. There are critical interests and broad needs for integrated imaging of blood flow and metabolism in both clinical and research applications.

Conditions

Healthy Subjects; Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental: PET/CT scans

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

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DRUG

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.

11C-butanol

Intervention Type: DRUG

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.

Interventions

18F-FDG

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.

Intervention Type: DRUG

11C-butanol

Each subject will undergo a dynamic 18F-FDG PET/CT scan (this drug is FDA approved) and a dynamic 11C-butanol PET/CT scan (this drug is under an IND) on the EXPLORER total-body PET/CT system. The two scans will be performed on the same day or within a period of up to two weeks depending on subject, imaging agent and scanner availability.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults (age ≥ 18 years old)
• Ability to understand and willingness to sign an informed consent form
• Ability to adhere to the study visit schedule and other protocol requirements.
• Willing and able to fast for at least 6 hours before and for the duration of the scan
• No strenuous exercise for 24 hours prior to being scanned
• Willing to lie on the scanner bed for up to 60 minutes
• Free of active COVID-19 symptoms

• Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in normal tissue perfusion and/or metabolism.

• Patients with clinically acute or chronic conditions such as cardiovascular, cardiometabolic, or cardiopulmonary diseases, which may include but are not limited to ischemic heart disease, myocarditis, arrhythmias, heart failure, nonalcoholic fatty liver disease, COVID-related sequala, diabetes, hypertension, or renal disease that would result in changes in normal tissue perfusion and/or metabolism.

Exclusion Criteria

Participants are not eligible if they meet ANY of the following criteria:

• Self-reported history of dysphoria or anxiety in closed spaces
• Body weight >240 kg due to limitations of the scanner bed
• Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)
• Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG
• Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
• Prisoners
• Any condition that would prevent the understanding or rendering of informed consent.
• Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guobao Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Research Team

Role: CONTACT

916-731-9004

Facility Contacts

Dana Little, MS

Role: primary

dalittle@ucdavis.edu

916-734-7749

Other Identifiers

1R01EB033435-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1921252

Identifier Type: -

Identifier Source: org_study_id