NCT01881880

Brief Summary

Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients. Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
424

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

6 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

November 19, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 29, 2024

Status Verified

June 1, 2013

Enrollment Period

2.7 years

First QC Date

March 22, 2013

Last Update Submit

May 27, 2024

Conditions

Breast Cancer

Keywords

TomosynthesisMammographyBreast cancer

Outcome Measures

Primary Outcomes (1)

  • diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.

    In all sites, Mammography and Tomosynthesis will be standardised and performed according to the Combo mode with 2 views for each breast. Any additional breast lesion assigned a BI-RAD 4 or 5 score after the full staging work-up will be biopsied under the best imaging method. (BIRADS scale : BIRADS 4a or higher is considered to be positive for cancer ) The Gold Standard diagnosis is defined as the final diagnosis at 1 year on the basis of the most severe histopathologic result (surgery, biopsy) for that lesion. A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level.

    1 year

Secondary Outcomes (2)

  • performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity

    1 year

  • performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality

    1 year

Study Arms (1)

Tomosynthesis

OTHER

Bilateral mammography with 4 views Tomosynthesis

Device: Bilateral mammography with Tomosynthesis

Interventions

Bilateral mammography with TomosynthesisDEVICE

no intervention pre specified to be administered to participants

Tomosynthesis

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women at least 40 years old
  • Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)

You may not qualify if:

  • Subjects with BRCA mutation or at high genetic risk
  • Subjects who have breast implants
  • Personal history of breast cancer
  • Subjects who are pregnant or who think they may be pregnant
  • Subjects who are breast-feeding
  • Subjects who are unable or unwilling to tolerate study constraints
  • Subjects unable or unwilling to undergo informed consent
  • Subject with no rights from the national health insurance programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Private Hospital oh Antony

Antony, 92169, France

Location

UH Grenoble

Grenoble, 34043, France

Location

Oscar Lambret Center

Lille, 59000, France

Location

Jean Mermoz Hospital

Lyon, 69008, France

Location

UH Montpellier

Montpellier, 34295, France

Location

Hospital Valenciennes

Valenciennes, 59322, France

Location

Related Publications (1)

  • Fontaine M, Tourasse C, Pages E, Laurent N, Laffargue G, Millet I, Molinari N, Taourel P. Local Tumor Staging of Breast Cancer: Digital Mammography versus Digital Mammography Plus Tomosynthesis. Radiology. 2019 Jun;291(3):594-603. doi: 10.1148/radiol.2019182457. Epub 2019 Apr 9.

    PMID: 30964425DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Patrice Taourel

    UH Montpellier

    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
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

June 20, 2013

Study Start

November 19, 2012

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

May 29, 2024

Record last verified: 2013-06

Locations

FR(6)