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Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

40 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Patrice Taourel

Investigator Role:

Principal Investigator

Investigator Affiliation:

UH Montpellier


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

December 2012

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Tomosynthesis
  • Mammography
  • Breast cancer
  • Breast Neoplasms