68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer

Breast Carcinoma Clinical Trial

Official title:

A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831711
• Other study ID #: IRB-48150
• Secondary ID: NCI-2019-00237BR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 19, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Estrogen Receptor Positive

Intervention

Drug:
• Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo PET/MRI
• Positron Emission Tomography
Undergo PET/MRI

Device:
• Investigational software and coils in PET/MR scan
General Electric (GE) Healthcare non-approved PET scanner coils and software

Locations

Country	Name	City	State
United States	Stanford Cancer Institute Palo Alto	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Andrei Iagaru	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 2 hours