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Single-tracer Multiparametric PET Imaging

ConditionsHealthy SubjectsCardiovascular Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Experimental: PET/CT scansExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
during the procedure

Secondary outcomes

1

Metabolism change when using Butanol

The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using Butanol tracer measured in SUV

Time frame
during the procedure
2

Metabolism change when using FDG

The secondary endpoint is to assess the changes in metabolism between healthy subjects and patients using FDG tracer measured in SUV

Time frame
during the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
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