Clinical trial · Interventional
SUV on PSMA PET/CT in Non-Prostate Tumors
NCT03841760CI-TRIAL-00065523terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollement
Summary
Brief summary (as posted)
The objective of this pilot study is to evaluate if 18F-DCFPyL PET/CT or 68Ga-PSMA-11 PET/CT can be used for detection and staging of PSMA-expressing non-prostate tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA PET/CT
- description
- One (1) PSMA PET/CT scan with with either PSMA-11 or DCFPyL
- interventionNames
- Diagnostic Test: PSMA PET/CT
Primary outcomes (1)
- measure
- Confirm PSMA PET uptake in tumors studied
- timeFrame
- Immediate
- description
- 1\. To confirm 18F-DCFPyL PET/CT or 68Ga-PSMA-11 uptake in the known tumor or other lesions found on PSMA PET/CT. The threshold for a positive lesion is a semi-quantitative measurement of activity: SUVmax \> 4 in lesions larger than 1.5 cm (so as to offset PET partial volume effect or "camera limitations"). IF SUVmax \> 4, the tumor is positive for PSMA PET/CT; If not, the tumor is negative for PSMA PET/CT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older, able to understand and provide written informed consent * The patient has a tumor known or suspected to have PSMA expression, as reported in the literature or by positive histopathological staining for PSMA. * The known or suspected tumor must fall into one of the following categories: carcinoma, sarcoma, or hematologic cancer. * ECOG performance status 0 - 3, inclusive * Under referring physician's care * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation Exclusion Criteria: * Patients with neoplasm known in literature to not have PSMA expression, unless patient specific tissue sampling shows PSMA staining on histopathology. * Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter) * Patients with unmanageable claustrophobia * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.