The Prone to Supine Breast MRI Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | July 12, 2018 |
| End Date: | August 2019 |
| Contact: | Richard J Barth, MD |
| Email: | cancer.research.nurse@dartmouth.edu |
| Phone: | 800-639-6918 |
The purpose of this study is to determine whether a supine MRI obtained immediately after a
standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast
material, would be of sufficient quality to allow the Radiologist to define the tumor edges
("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.
standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast
material, would be of sufficient quality to allow the Radiologist to define the tumor edges
("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.
The purpose of this study is to find out whether additional MRI images taken with patients in
a different position after completing a standard MRI are of sufficient quality to allow a
radiologist to identify the edges of the tumor.
These additional MRI images will only take about 10-15 minutes to obtain and will not require
a second injection of contrast material.The information gathered in this study will make it
more feasible to use a new device called the "breast cancer locator" to help surgeons more
accurately remove breast cancers.
a different position after completing a standard MRI are of sufficient quality to allow a
radiologist to identify the edges of the tumor.
These additional MRI images will only take about 10-15 minutes to obtain and will not require
a second injection of contrast material.The information gathered in this study will make it
more feasible to use a new device called the "breast cancer locator" to help surgeons more
accurately remove breast cancers.
Inclusion Criteria:
- Age > 18 years.
- Female gender.
- Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- A diagnostic breast MRI is considered to be clinically indicated.
- Ability to voluntarily provide informed consent to participate prior to any
study-related assessments/procedures being conducted.
Exclusion Criteria:
- Absolute contraindication to MRI, including presence of implanted electrical device
(pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near
eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life-
threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- Patients who have received neoadjuvant chemotherapy.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Phone: 800-639-6918
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