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

University of California (UC) Davis

Status: Invitation-only

Conditions: Breast Cancer; Neuroendocrine Tumors; Prostate Cancer

Treatments: Diagnostic Test: Total-body PET imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05160480

1837303

EXPLLN21-01

Details and patient eligibility

About

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).

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

9 participants in 1 patient group

Total-body PET scan

Description:

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.

Treatment:

Diagnostic Test: Total-body PET imaging