Study Stopped
Slow Accural
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
1 other identifier
interventional
9
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Feb 2012
Shorter than P25 for phase_3 breast-cancer
3 active sites
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
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 2, 2016
August 1, 2016
1.1 years
March 29, 2012
August 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess if pre-operative MRI reduces incidence of re-excisions required
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
2 years
Secondary Outcomes (5)
Total Mastectomy Rates
2 years
Number of biopsies
2 years
Local-regional recurrence rates
2 years
Time from diagnosis to local therapy
2 years
Number of malignancies in contralateral breast
2 years
Study Arms (2)
MRI
ACTIVE COMPARATORMRI
No MRI
NO INTERVENTIONNo MRI
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Faulkner Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
February 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 2, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share