Recruiting

18F-PSMA, 18F-FES, 68Ga DOTATATE

Sponsor:

UCLA

Code:

NCT05160480

Conditions

Prostate Cancer

Breast Cancer

Neuroendocrine Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total-body PET imaging

Study Details

Brief summary:

The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).

Conditions

Prostate Cancer

Breast Cancer

Neuroendocrine Tumors

Study ID

NCT05160480

Start date

Jun 7, 2024

Status verified date

Oct, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

9 participants

Anticipated

Interventions and Outcome Measures

Arms

Total-body PET scan

All participants will receive a dynamic PET scan for up to 90 minutes. This will be followed by two 30 minutes static PET scans at 3 hours +/-20 minutes and 6 hours +/-20 minutes post injection. Subjects injected with 18F-PSMA or 18F-FES will receive a 40 minute scan at 9 hours +/-20 minutes post injection.

Interventions

Total-body PET imaging

Total-body PET imaging at different timepoints

Primary outcome measure

  • measure radiotracer avidity [ Time Frame: One study imaging visit lasting up to 10 hours ]

Central Contacts and Locations

Central contacts

Clinical Research Team

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

Locations

UC Davis EXPLORER Molecular Imaging Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Dana Little, MS

916-734-7749dalittle@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.