Breast Carcinoma, Estrogen Receptor Positive
Conditions
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 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes. After completion of study, patients are followed up at 24-72 hours, and then for 12 months.
Interventions
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo PET/MRI
PROCEDUREPositron Emission Tomography
Undergo PET/MRI
General Electric (GE) Healthcare non-approved PET scanner coils and software
Sponsors
General Electric
Andrei Iagaru
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI | up to 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (68-Ga RM2, PET/MRI) Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Diagnostic (68-Ga RM2, PET/MRI) |
|---|---|
| Age, Continuous | 55.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
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.
Time frame: up to 2 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (68-Ga RM2, PET/MRI) | Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI | Breast Lesions | 4 Participants |
| Diagnostic (68-Ga RM2, PET/MRI) | Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI | Lymph Node Lesions | 1 Participants |