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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05160480
Enrollment
9
Registered
2021-12-16
Start date
2024-06-07
Completion date
2026-09-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neuroendocrine Tumors, Prostate Cancer

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).

Interventions

DIAGNOSTIC_TESTTotal-body PET imaging

Total-body PET imaging at different timepoints

Sponsors

University of California, Davis
Lead SponsorOTHER
Lantheus Medical Imaging
CollaboratorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
measure radiotracer avidityOne study imaging visit lasting up to 10 hoursmeasure 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLorenzo Nardo, MD

University of California, Davis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026