The Prone to Supine Breast MRI Trial

NCT ID: NCT03573804

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2020-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prone to Supine MRI

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy B. Rooney

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy B Rooney, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28766199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10713939 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D17168

Identifier Type: -

Identifier Source: org_study_id