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RECRUITING

NCT06014515

EARLY_PHASE1

Single-tracer Multiparametric PET Imaging

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-02-14

Completion Date

2033-08

Last Updated

2026-03-10

Healthy Volunteers

Yes

Conditions

Healthy Subjects Cardiovascular Disease

Interventions

DRUG

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.

DRUG

11C-butanol

Inclusion Criteria: 1. Inclusion Criteria for all research participants: * 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 2. Inclusion Criteria for healthy volunteers only: • Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in normal tissue perfusion and/or metabolism. 3. Inclusion Criteria for patients with disease: * 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.

Locations (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, United States