Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00237 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BRS0098 | Other Identifier | OnCore | |
| IRB-48150 | Other Identifier | Stanford IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| General Electric | INDUSTRY |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (68-Ga RM2, PET/MRI) | Experimental | Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford Cancer Institute Palo Alto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (68-Ga RM2, PET/MRI) | Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Magnetic Resonance Imaging | Procedure | Undergo PET/MRI |
|
|
| Positron Emission Tomography | Procedure | Undergo PET/MRI |
|
|
| Investigational software and coils in PET/MR scan | Device | General Electric (GE) Healthcare non-approved PET scanner coils and software |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Number of lesions identified on 68Ga-RM2 PET/MRI
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (68-Ga RM2, PET/MRI) | Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 2 hours |
|
|
|
up to 72 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (68-Ga RM2, PET/MRI) | Patients received 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
Early termination led to a small numbers of subjects analyzed.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrei Iagaru, MD | Stanford University | 650-725-4711 | aiagaru@stanford.edu |
| Nov 20, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582579 | BAY 86-7548 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|