A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

• Conditions: Breast Cancer; Prostate Cancer; Neuroendocrine Tumors
• Interventions: Diagnostic Test: Total-body PET imaging

• Registration Number: NCT05160480
• Lead Sponsor: University of California, Davis

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-16
• Study Start: 2024-06-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 9

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total-body PET scan	Total-body PET imaging	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.

Primary Outcome Measures

Name	Time	Method
measure radiotracer avidity	One study imaging visit lasting up to 10 hours	measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.

Trial Locations

Locations (1)

UC Davis EXPLORER Molecular Imaging Center; 🇺🇸 Sacramento, California, United States