Recruiting
Early Phase 1

PET Imaging

Sponsor:

UCLA

Code:

NCT06014515

Conditions

Healthy Subjects

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

18F-FDG

11C-butanol

Study Details

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.

Conditions

Healthy Subjects

Cardiovascular Disease

Study ID

NCT06014515

Start date

Feb 14, 2024

Status verified date

Jul, 2025

Completion date

Aug, 2033

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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

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.

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.

Primary outcome measure

  • Blood Flow [ Time Frame: during the procedure ]

Central Contacts and Locations

Central contacts

Clinical Research Team

916-731-9004research-radiology-som@health.ucdavis.edu

Locations

UC Davis EXPLORER Molecular Imaging Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Dana Little, MS

916-734-7749dalittle@ucdavis.edu

Principal Investigator:

Guobao Wang, PhD

More Information

Sponsor

University of California, Davis

Last update posted

Mar 10, 2026

Last verified

Jul, 2025

Keywords

  • total body positron emission tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-10.