68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03831711|
Recruitment Status : Suspended (Logistics)
First Posted : February 6, 2019
Last Update Posted : December 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Estrogen Receptor Positive||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||Phase 1 Phase 2|
I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer|
|Actual Study Start Date :||March 19, 2019|
|Estimated Primary Completion Date :||June 18, 2023|
|Estimated Study Completion Date :||June 18, 2024|
Experimental: Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
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
General Electric (GE) Healthcare non-approved PET scanner coils and software
- Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI [ Time Frame: 24 months ]Number of lesions will be 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831711
|United States, California|
|Stanford Cancer Institute Palo Alto|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Andrei Iagaru||Stanford Cancer Institute Palo Alto|