Clinical trial · Observational
A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
NCT05160480CI-TRIAL-00105143enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total-body PET imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Total-body PET scan
- description
- 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.
- interventionNames
- Diagnostic Test: Total-body PET imaging
Primary outcomes (1)
- measure
- measure radiotracer avidity
- timeFrame
- One study imaging visit lasting up to 10 hours
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.