NCT01303419

Brief Summary

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2010

Geographic Reach
5 countries

5 active sites

Status
terminated

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

April 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2012

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

April 10, 2019

Completed
Last Updated

April 10, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

February 18, 2011

Results QC Date

February 27, 2019

Last Update Submit

March 19, 2019

Conditions

Breast Cancer

Keywords

mammography

Outcome Measures

Primary Outcomes (5)

  • Completion of CE-BMRI and DE-CEDM

    Subjects have completed both CE-BMRI and DE-CEDM scan types

    Approximately 8 weeks

  • Average Maximum Lesion Size by CE-BMRI Scan

    Average maximum lesion size when scanned using CE-BMRI

    Within 1 week of CE-BMRI scan

  • Average Maximum Lesion Size by DE-CEDM

    Average maximum lesion size when scanned using DE-CEDM

    Within 1 week of DE-CEDM scan

  • Average Maximum Lesion Size by Histology Outcome

    Average maximum lesion size as described in histology report.

    Approximately 1 week; upon completion of histology report

  • Multi-reader Evaluation of Images

    Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.

    This outcome did not occur due to premature study stop.

Study Arms (1)

CE-BMRI

EXPERIMENTAL

Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.

Device: CE-BMRIDevice: DE-CEDM

Interventions

CE-BMRIDEVICE

Contrast-enhanced breast imaging using Magnetic Resonance

CE-BMRI
DE-CEDMDEVICE

Breast imaging using Dual-energy, contrast-enhanced digital mammography

CE-BMRI

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman 21 years of age or older
  • The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
  • Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
  • Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.

You may not qualify if:

  • Woman who has already had a lumpectomy for the index lesion.
  • Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
  • Woman who is pregnant or who believe she may be pregnant.
  • Woman who has breast implant.
  • Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

AZ St-Jan Brugge AV

Bruges, Belgium

Location

Sunnybrook Health Science Centre

Toronto, Canada

Location

Institut Goustave Roussy

Villejuif, France

Location

Institut fur Radiologie, Charite

Berlin, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Jean-Paul Antonini
Organization
GE Healthcare
Jean-Paul.antonini@ge.com
+33 130709703

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 24, 2011

Study Start

April 1, 2010

Primary Completion

June 30, 2012

Study Completion

June 30, 2012

Last Updated

April 10, 2019

Results First Posted

April 10, 2019

Record last verified: 2019-03

Locations

BE(1)US(1)CA(1)FR(1)DE(1)