A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

NCT01929395 | Completed Results DMC

• 2 other identifiers: D0928NCI-2011-03481
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Conserving Surgery; Breast diagnostics; Breast imaging

Outcome Measures

Primary Outcomes (2)

• The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.

  Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.

  From baseline MRI to intraoperative measurements: 30 days

• To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.

  The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.

  30 days from surgery

Secondary Outcomes (1)

• Differences Between the Two Groups in the Volume of Breast Tissue Removed

  30 days from surgery

Study Arms (2)

Arm 1 addition of supine MRI to conventional imaging

ACTIVE COMPARATOR

Arm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery.

Device: Supine MRI

Arm 2 randomize to SOC vs supine MRI + SOC

ACTIVE COMPARATOR

Arm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.

Device: Supine MRI

Interventions

Supine MRI DEVICE

A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.

Arm 1 addition of supine MRI to conventional imaging; Arm 2 randomize to SOC vs supine MRI + SOC

Eligibility Criteria

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

You may qualify if:

• Age greater than/equal to 18 years
• Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
• Patient desire to undergo breast surgery
• \. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.
• Age greater than/equal to 18 years
• Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
• The tumor is visible and enhances on prone MRI and is \>1 cm in greatest diameter.
• Determination by the surgeon that the neoplasm is non-palpable.A patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study
• Patient desire to undergo breast conserving surgery
• Patients will have provided informed consent to participate, documented by their signature on the study consent form.The process of informed consent will be documented in the medical record and a copy of the signed consent form will be given to the patient.

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 (creatinine \> 2.0)
• History of median sternotomy
• Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).
• Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast. An eligibility worksheet will be completed for each patient prior to enrollment and will be signed and dated by the surgeon investigator

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

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: Dr Richard J. Barth Jr.
• Organization: Dartmouth Hitchcock Medical Center

Richard.J.Barth.Jr@hitchcock.org

(603) 650-9479

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, General Surgery

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: August 27, 2013
• Study Start: September 1, 2009
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Locations

US (1)