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

March 9, 2026 updated by: University of California, Davis
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • UC Davis EXPLORER Molecular Imaging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited by physicians, primary care physicians, radiologists, and research team members who will identify potential participants and notify a research team member to assist with consenting. The research team will also screen potential patients from the oncology clinical schedules. When a potential participant is identified, a member of the research team will contact the referring physician and/or a clinical team member in charge of the patient's care and request permission to contact the patient. If the referring physician/clinical team agrees, a member of the research team will contact the patient.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Total-body PET imaging
Total-body PET imaging at different timepoints

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Lantheus Medical Imaging

Investigators

  • Principal Investigator: Lorenzo Nardo, MD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1837303
  • EXPLLN21-01 (Other Identifier: University of California Davis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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