Breast Cancer Clinical Trial

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

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).

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT05160480

Recruitment Status:

Not yet recruiting

Sponsor:

University of California, Davis

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

9

Study ID:

NCT05160480

Recruitment Status:

Not yet recruiting

Sponsor:


University of California, Davis

How clear is this clinincal trial information?

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