The Prone to Supine Breast MRI Trial

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03573804

Run by

Dartmouth-Hitchcock Medical Center

People needed

72

Starts

2018-07-12

Expected to finish

2020-07-31

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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