Total-body PET with FDA-approved Tracers Beyond 18F-FDG
Official title: A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
Run by University of California, Davis · NCT05160480 · Data updated 2026-11-12
This small, non-randomized study tests how well the total-body PET/CT scanner can image prostate cancer, breast cancer, and neuroendocrine tumors using three approved tracers to see if images are clearer or more informative.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Status | Recruiting |
| Started | June 7, 2024 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT05160480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with suspected or known metastatic prostate cancer, breast cancer, or neuroendocrine tumors who have had a recent prior imaging study.
✕Probably not a fit
Patients who do not show improved visualization with these tracers or who cannot tolerate the scan duration may derive no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers are using the world’s first total-body PET/CT scanner to image patients with suspected or known metastatic disease from prostate cancer, breast cancer, or neuroendocrine tumors. The study examines three FDA-approved tracers—18F-PSMA, 18F-FES, and 68Ga DOTATATE (or 64Cu-DOTATATE)—to see how each performs on total-body imaging. Participants will undergo total-body PET scans at multiple timepoints, with eligibility limited to adults who can consent and who have had recent prior imaging suggesting metastasis. This is an observational pilot intended to characterize image quality and potential insights from total-body PET using these tracers.
Why it matters
Potential benefit: If successful, the approach could improve how metastases are detected and tracked, potentially guiding treatment decisions.
How similar studies have gone: Prior studies with total-body PET and specific tracers have shown promising imaging capabilities, but this exact approach is exploratory and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
18F-PSMA (n=3) and 68Ga-PSMA (n=3) Inclusion criteria: * Persons \>18 yo with suspected prostate cancer metastasis * Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date. 68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3) Inclusion Criteria: * Persons \> 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs) * Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date. Exclusion Criteria: • Recent administration of long-acting somatostatin analogs Exclusion Criteria for all participants: * Adults unable to consent * Pregnant/lactating persons * Prisoners * Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner * Uncontrolled claustrophobia * Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and/or adhering to study related procedures or interfere with participant safety
Where it's running
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UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, United States Recruiting
Study contacts
- Principal investigator: Lorenzo Nardo, MD — University of California, Davis
- Study coordinator: Clinical Research Team
- Email: research-radiology-som@health.ucdavis.edu
- Phone: 916-731-9004
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.