The Prone to Supine Breast MRI Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Prone to Supine MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prone to Supine MRI; The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Other: Prone to Supine MRI; The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Successful Segmentation of Supine MRI Images	Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor	Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.	30 minutes
Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary	Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.	30 minutes
Enhancement Quantification- Tumor-to-Background Ratio	Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio	30 minutes
Time to Position and Obtain Supine Images	Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.	30 Minutes
Overall Comfort for Prone and Supine Positions	Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.	Within 15 minutes of the scan

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Timothy B Rooney, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer Locator
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D17168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No