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

NCT05160480 | Enrolling By Invitation

• 2 other identifiers: 1837303EXPLLN21-01
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer; Breast Cancer; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Total-body PET imaging DIAGNOSTIC_TEST

Total-body PET imaging at different timepoints

Total-body PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)
• 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.

You may not qualify if:

• Recent administration of long-acting somatostatin analogs
• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

• Lorenzo Nardo, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: June 7, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)