Clinical trial NCT03573804: The Prone to Supine Breast MRI Trial
Official title: The Prone to Supine Breast MRI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer Locator
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Number of Successful Segmentation of Supine MRI Images
timeFrame: 30 minutes
Secondary outcomes:
measure: Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor
timeFrame: 30 minutes
measure: Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary
timeFrame: 30 minutes
measure: Enhancement Quantification- Tumor-to-Background Ratio
timeFrame: 30 minutes
measure: Time to Position and Obtain Supine Images
timeFrame: 30 Minutes
measure: Overall Comfort for Prone and Supine Positions
timeFrame: Within 15 minutes of the scan
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Timothy B Rooney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barth RJ Jr, Krishnaswamy V, Paulsen KD, Rooney TB, Wells WA, Rizzo E, Angeles CV, Marotti JD, Zuurbier RA, Black CC. A Patient-Specific 3D-Printed Form Accurately Transfers Supine MRI-Derived Tumor Localization Information to Guide Breast-Conserving Surgery. Ann Surg Oncol. 2017 Oct;24(10):2950-2956. doi: 10.1245/s10434-017-5979-z. Epub 2017 Aug 1.
citation: Leong CS, Daniel BL, Herfkens RJ, Birdwell RL, Jeffrey SS, Ikeda DM, Sawyer-Glover AM, Glover GH. Characterization of breast lesion morphology with delayed 3DSSMT: an adjunct to dynamic breast MRI. J Magn Reson Imaging. 2000 Feb;11(2):87-96. doi: 10.1002/(sici)1522-2586(200002)11:23.0.co;2-e.