NCT01409226

Brief Summary

This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve in diagnosing breast cancer in women with high-risk of breast cancer.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

August 2, 2011

Last Update Submit

April 3, 2012

Conditions

Breast CancerBRCA1 MutationBRCA2 Mutation

Keywords

high-risk of breast cancerBRCA1 mutation carrierBRCA2 mutation carrierdiagnosticMRIBI-RADS 4mammographically occult

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with mammographically occult breast cancer detected by 3.0-T MRI

    This is the frequency of mammographically occult breast cancer detected by 3.0-T MRI in a subset of high risk women with a suspicious mammographically detected lesion.

    2 years

Secondary Outcomes (3)

  • Percentage of participants with incidental lesions detected by MRI

    2 years

  • False positive rate

    2 years

  • False negative rate

    2 years

Study Arms (1)

MRI

EXPERIMENTAL
Device: 3.0-T MRIProcedure: biopsy

Interventions

3.0-T MRIDEVICE

Participants undergo MRI prior to biopsy.

MRI
biopsyPROCEDURE

Participants undergo breast biopsy after 3.0-T MRI.

MRI

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women at high risk of developing breast cancer as outlined by the American Cancer society (ACS): women with known predisposing mutations (in BRCA1, 2 or PTEN genes), women with first degree relative who is a known carrier or has a 20% or more life time risk of breast cancer.
  • The above high-risk women with a suspicious lesion classified as BIRADS 4 that is detected on mammography. Since the spatial resolution of 3.0-T breast MRI is similar to digital mammography, there is no limitation to the size of the mammographic lesion.

You may not qualify if:

  • Pregnancy or lactating women
  • Contraindications for MRI:
  • electrical implants (e.g. cardiac pacemakers or perfusion pumps)
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  • weight over 350 lbs
  • Although a women meets our criteria for high risks for breast cancer and has an abnormal mammogram, she will be excluded from our study if her insurer does not provide payment for the breast MRI. The suspicious lesion will be biopsied under mammographic guidance as part of her standard of care. The third party carriers have been reimbursing payment for a breast MRI in these high risk women, especially after the ACS guidelines were released in 2007. Therefore, this outcome is unlikely to occur.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsDisease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Linda Moy, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

August 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

US(1)