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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05160480
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Davis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lorenzo Nardo, MD
Principal Investigator Affiliation	University of California, Davis
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Prostate Cancer, Breast Cancer, Neuroendocrine Tumors

Arms & Interventions

Arms

Experimental: 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.

Interventions

Diagnostic Test: - Total-body PET imaging

Total-body PET imaging at different timepoints

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Address

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816

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