Single-tracer Multiparametric PET Imaging

NCT06014515 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 19212521R01EB033435-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

total body positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Blood Flow

  The primary study endpoint is to evaluate if the blood flow estimated with 18F-FDG is quantitatively equal to the blood flow measured with the flow-dedicated tracer 11C-butanol measured in ml/min/g.

  during the procedure

Secondary Outcomes (2)

• Metabolism change when using Butanol

  during the procedure

• Metabolism change when using FDG

  during the procedure

Study Arms (1)

Experimental: PET/CT scans

EXPERIMENTAL

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

Drug: 18F-FDG; Drug: 11C-butanol

Interventions

18F-FDG 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.

Experimental: PET/CT scans

11C-butanol 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.

Experimental: PET/CT scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Guobao Wang, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will undergo two PET/CT scans with two different radiotracers.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 28, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2033
• Last Updated: March 10, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)