Clinical trial · Interventional
68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
NCT03831711CI-TRIAL-00072199completedPhase 1 / Phase 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)
This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.
Conditions
Conditions (2)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Estrogen Receptor Positive | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 | Drug | — | UNRESOLVED |
| Investigational software and coils in PET/MR scan | Device | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (68-Ga RM2, PET/MRI)
- description
- Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
- interventionNames
- Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Device: Investigational software and coils in PET/MR scan
Primary outcomes (1)
- measure
- Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
- timeFrame
- up to 2 hours
- description
- Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy). * Able to provide written consent * Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent) Exclusion Criteria: * Less than 18 years-old at the time of radiotracer administration * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance * Renal function impairment preventing administration of MRI contrast * Metallic implants (contraindicated for MRI)
References
Publications (0)
Data not yet available
No reference posted for this study.