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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05160480
• Other study ID #: EXPLLN21-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Neuroendocrine Tumors
• Prostate Cancer

Intervention

Diagnostic Test:
• Total-body PET imaging
Total-body PET imaging at different timepoints

Locations

Country	Name	City	State
United States	UC Davis EXPLORER Molecular Imaging Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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