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

NCT ID: NCT05160480

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2026-09-01

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 Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Total-body PET imaging

Intervention Type: DIAGNOSTIC_TEST

Total-body PET imaging at different timepoints

Interventions

Total-body PET imaging

Total-body PET imaging at different timepoints

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Nardo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, United States

Countries

United States

Other Identifiers

EXPLLN21-01

Identifier Type: OTHER

Identifier Source: secondary_id

1837303

Identifier Type: -

Identifier Source: org_study_id