Phase 2
Completed N=5
68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
Breast Cancer · Estrogen Receptor Positive
Source: ClinicalTrials.gov NCT03831711 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI — 4; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI |
4; 1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03831711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.