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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prostate Cancer, Breast Cancer, Neuroendocrine Tumors

Intervention / Treatment
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* Diagnostic Test: Total-body PET imaging


Participation Criteria
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Eligibility Criteria
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18F-PSMA (n=3) Inclusion criteria: Men >18 yo with suspected prostate cancer metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained not earlier than 4 months from the research scan date. 68Ga 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 18F-FES (n=3): Persons > 18 yo with recurrent or metastatic breast cancer Prior imaging study (CT, and/or US, and/or MRI, and/or bone scan and/or FDG PET/CT) suspicious for tumor, obtained not earlier than 4 months from the research scan date. Biopsy proven ER-positive breast cancer (any location) in the past 6 months Exclusion Criteria: • History of ER modulators and ER down-regulators such as tamoxifen and fulvestrant in the past 8 and 28 weeks, respectively 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 subject from participating and/or adhering to study related procedures or interfere with subject safety

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total-body PET scan<br>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. | Diagnostic Test: Total-body PET imaging<br>* Total-body PET imaging at different timepoints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One study imaging visit lasting up to 10 hours |