Clinical trial · Expanded Access
Expanded Access [Ga-68] PSMA-11 PET Imaging
NCT04800068CI-TRIAL-00056080no longer availableClinicalTrials.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)
In this expanded access IND study, Mayo Clinic in Rochester MN offers \[Ga-68\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [Ga-68] PSMA-11 PET/CT | Diagnostic Test | — | UNRESOLVED |
| [Ga-68] PSMA-11 PET/MR | Diagnostic Test | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Participant Groups There are two participant groups; please refer to the inclusion details below: Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria): 1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more 2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10) 3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI) Biochemically Recurrent prostate cancer group (must meet one of the criteria): 1. In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests 2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA Exclusion Criteria: Current exclusion criteria for both groups includes: 1. Patients unable to sign informed consent 2. Patient with a life expectancy less than 6 months 3. Additional exclusion criteria may be added based on demand
References
Publications (0)
Data not yet available
No reference posted for this study.