Status:
COMPLETED
68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
Lead Sponsor:
Andrei Iagaru
Collaborating Sponsors:
General Electric
Conditions:
Breast Carcinoma
Estrogen Receptor Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases OUTLINE: Patients receive 68-Ga-RM2 int...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03831711
Start Date
March 19 2019
End Date
November 15 2021
Last Update
December 13 2023
Active Locations (1)
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1
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304