Clinical trial · Interventional
68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
NCT03809078CI-TRIAL-00072929completedPhase 2Results postedClinicalTrials.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 objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
| 68Ga RM2 | Drug | — | UNRESOLVED |
| Investigational PET scanner coils and software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 68Ga RM2 first followed by 68Ga PSMA11
- description
- Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
- interventionNames
- Drug: 68Ga RM2
- Drug: 68Ga-PSMA-11
- Device: Investigational PET scanner coils and software
- type
- EXPERIMENTAL
- label
- 68Ga PSMA11 first followed by 68Ga RM2
- description
- Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
- interventionNames
- Drug: 68Ga RM2
- Drug: 68Ga-PSMA-11
- Device: Investigational PET scanner coils and software
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected prostate cancer * Planned prostate biopsy * Able to provide written consent * Karnofsky performance status of 50 (or ECOG/WHO equivalent) Exclusion Criteria: * Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Metallic implants (contraindicated for MRI)
References
Publications (1)
- RESULTDuan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17. PMID 36396456