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Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

This study has been terminated.
(Slow Accural)
Sponsor:
Information provided by (Responsible Party):
Mehra Golshan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01568346
First received: March 29, 2012
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.


Condition Intervention Phase
Breast Cancer
 Other: MRI
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Assess if pre-operative MRI reduces incidence of re-excisions required [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma


Secondary Outcome Measures:
  • Total Mastectomy Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Total Mastectomy Rates

  • Number of biopsies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of biopsies recommended and performed

  • Local-regional recurrence rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Local-regional recurrence rates in participants undergoing local therapy

  • Time from diagnosis to local therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The time from diagnosis to definitive local therapy

  • Number of malignancies in contralateral breast [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of malignancies identified int he contralateral breast


Estimated Enrollment: 348
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MRI
MRI
 Other: MRI
Breast MRI
No Intervention: No MRI
No MRI

Detailed Description:

This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.

The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must undergo definitive local therapy with either breast conserving therapy or mastectomy
  • Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
  • Able to undergo breast MRI

Exclusion Criteria:

  • Not pregnant or breastfeeding
  • No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
  • No prior mantle radiation
  • No locally advanced breast cancer
  • No diffuse malignant appearing microcalcifications requiring mastectomy
  • No known collagen vascular disease
  • No previous ipsilateral radiation
  • No participants who undergo surgery at an outside institution
  • No prior history of breast carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568346

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Faulkner Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Mehra Golshan, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01568346     History of Changes
Other Study ID Numbers: 11-330
Study First Received: March 29, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Newly diagnosed
Early stage

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013