The Prone to Supine Breast MRI Trial

NCT03573804 | Completed Results DMC

• 1 other identifier: D17168
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer Locator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor

  30 minutes

• Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary

  30 minutes

• Enhancement Quantification- Tumor-to-Background Ratio

  30 minutes

• Time to Position and Obtain Supine Images

  30 Minutes

• Overall Comfort for Prone and Supine Positions

  Within 15 minutes of the scan

Study Arms (1)

Prone to Supine MRI

EXPERIMENTAL

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

Interventions

Prone to Supine MRI 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.

Prone to Supine MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• 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.

  PMID: 28766199 BACKGROUND

• 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.

  PMID: 10713939 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Timothy B Rooney, MD, PI
• Organization: Dartmouth-Hitchcock

timothy.b.rooney@hitchcock.org

603-650-5000

Study Officials

• Timothy B Rooney, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: July 12, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)