A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total-body PET imaging.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Breast Cancer, Neuroendocrine Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Total-body PET imaging
Total-body PET imaging at different timepoints
Primary outcome measures
- measure radiotracer avidity [Time frame: One study imaging visit lasting up to 10 hours]
Eligibility 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
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 participant from participating and/or adhering to study related procedures or interfere with participant safety
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- UC Davis EXPLORER Molecular Imaging Center — Sacramento
Identifiers
NCT: NCT05160480 · 1837303 · EXPLLN21-01