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

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).

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Key information

Conditions

Prostate Cancer Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total-body PET imaging

Diagnostic Test

Total-body PET imaging at different timepoints

Primary outcomes

measure radiotracer avidity

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

Lantheus Medical Imaging

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 16, 2021
Registry last updated: Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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