Healthy SubjectsEarly Phase 1NCT06014515
Single-tracer Multiparametric PET Imaging
A Early Phase 1 study testing 18F-FDG and 11C-butanol in people with Healthy Subjects and Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Cardiovascular Disease
- What is being tested?
- 18F-FDG and 11C-butanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to Aug 2033
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Willing to lie on the scanner bed for up to 60 minutes
- Free of active COVID-19 symptoms
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816
Dana Little, MS, 916-734-7749, dalittle@ucdavis.edu
Guobao Wang, PhD
About this study
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.
Read the 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
- Being tested
- 18F-FDG, 11C-butanol
- Keywords
- total body positron emission tomography
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
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-butanolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 18F-FDG; Drug: 11C-butanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the procedure
Secondary outcomes (2)
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
Measured: during the procedure
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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start14 Feb 2024
- Primary completionAug 2028 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo two PET/CT scans with two different radiotracers.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Guobao Wang, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014515
- Sponsor's protocol ID
- 1921252
- Other IDs
- 1R01EB033435-01
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-tracer Multiparametric PET Imaging
- ClinicalTrials.gov ID
- NCT06014515
- Acronym / sponsor ID
- 1921252
- Conditions
- Healthy Subjects, Cardiovascular Disease
- Keywords
- total body positron emission tomography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo two PET/CT scans with two different radiotracers.
| Arm | Type | Receives |
|---|---|---|
| Experimental: PET/CT scans | Experimental | Drug: 18F-FDG, Drug: 11C-butanolEach 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Inclusion Criteria for all research participants:
- Inclusion Criteria for healthy volunteers only:
- Inclusion Criteria for patients with disease:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGEach 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 | Experimental: PET/CT scans |
| 11C-butanolEach 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 | Experimental: PET/CT scans |
Primary outcome
Blood Flow
Time frame: during the procedure
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.
2 secondary outcomes
Metabolism change when using Butanol
Time frame: during the procedure
Metabolism change when using FDG
Time frame: during the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guobao Wang, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG and 11C-butanol in people with Healthy Subjects and Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Team (916-731-9004, research-radiology-som@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.