NCT06014515 Single-tracer Multiparametric PET Imaging
| NCT ID | NCT06014515 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Healthy Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-02-14 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Guobao Wang, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06014515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06014515 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06014515 currently recruiting?
Yes, NCT06014515 is actively recruiting participants. Contact the research team at research-radiology-som@health.ucdavis.edu for enrollment information.
Where is the NCT06014515 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06014515 clinical trial?
NCT06014515 is sponsored by University of California, Davis. The principal investigator is Guobao Wang, PhD at University of California, Davis. The trial plans to enroll 60 participants.