NCT02335671

Brief Summary

The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

7.9 years

First QC Date

January 7, 2015

Last Update Submit

February 27, 2023

Conditions

Early Stage Breast CancerBreast Cancer Stage IBreast Cancer Stage II

Keywords

Early Stage Breast CancerBreast Conserving SurgeryBreast Cancer Stage IBreast Cancer Stage II

Outcome Measures

Primary Outcomes (1)

  • To evaluate the accuracy of MRI in detecting tumor boundaries

    2 Years

Secondary Outcomes (3)

  • To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results

    2 Years

  • To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.

    2 Years

  • To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion

    2 Years

Study Arms (1)

Intra-operative Magnetic Resonance Imaging (MRI)

EXPERIMENTAL

* Preoperative diagnostic MRI * Intra-operative MRI * Standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated * Specimen to Pathology and Mass Spectrometer (Analysis of Tissue Sample)

Procedure: Intra-operative Magnetic Resonance Imaging (MRI)Other: Mass Spectrometer Analysis of Tissue Sample

Interventions

Intra-operative Magnetic Resonance Imaging (MRI)PROCEDURE
Intra-operative Magnetic Resonance Imaging (MRI)
Mass Spectrometer Analysis of Tissue SampleOTHER

Analysis of Tissue Sample

Intra-operative Magnetic Resonance Imaging (MRI)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be female
  • Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
  • Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
  • Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
  • Patient must meet standard MRI guidelines and be able and willing to undergo MRI
  • Age ≥18 years and \< 75.
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Participants with a known BRCA 1 or 2 mutation.
  • Participants with known Li-Fraumeni or Cowden's Disease.
  • Participants with prior mantle radiation.
  • Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
  • Participants who are pregnant.
  • Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
  • Participants with known active collagen vascular disease.
  • Participants with prior history of ipsilateral breast carcinoma.
  • Patients who have biopsy confirmed multi-centric disease.
  • Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure.
  • Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thanh Barbie, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 12, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

US(2)