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

N/AEnrolling By InvitationNCT05160480

University of California, Davis9 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer Breast Cancer Neuroendocrine Tumors

Interventions

Total-body PET imagingDIAGNOSTIC_TEST

Total-body PET imaging at different timepoints

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

measure radiotracer avidity

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.

Time frame: One study imaging visit lasting up to 10 hours