Breast Cancer Clinical Trial

The Prone to Supine Breast MRI Trial

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

72

Study ID:

NCT03573804

Recruitment Status:

Completed

Sponsor:

Dartmouth-Hitchcock Medical Center

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There is 1 Location for this study

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Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

72

Study ID:

NCT03573804

Recruitment Status:

Completed

Sponsor:


Dartmouth-Hitchcock Medical Center

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