Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

May 27, 2024 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

424

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antony, France, 92169
        • Private Hospital oh Antony
      • Grenoble, France, 34043
        • UH Grenoble
      • Lille, France, 59000
        • Oscar Lambret Center
      • Lyon, France, 69008
        • Jean Mermoz Hospital
      • Montpellier, France, 34295
        • UH Montpellier
      • Valenciennes, France, 59322
        • Hospital Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tomosynthesis
Bilateral mammography with 4 views Tomosynthesis
Device: Bilateral mammography with Tomosynthesis
no intervention pre specified to be administered to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity
Time Frame: 1 year

Concerning breasts lesions : assessing multicentricity by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions

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.
1 year
performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality
Time Frame: 1 year

concerning Breasts lesions : assessing multifocality by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Patrice Taourel, UH Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimated)

June 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8904 (R&D Number Newcastle Hospitals)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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