Clinical trial NCT01881880: Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
Official title: Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Tomosynthesis
Mammography
Breast cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 424
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity
timeFrame: 1 year
measure: performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality
timeFrame: 1 year
Other outcomes:
Locations:
city: Antony
country: France
facility: Private Hospital oh Antony
city: Grenoble
country: France
facility: UH Grenoble
city: Lille
country: France
facility: Oscar Lambret Center
city: Lyon
country: France
facility: Jean Mermoz Hospital
city: Montpellier
country: France
facility: UH Montpellier
city: Valenciennes
country: France
facility: Hospital Valenciennes
Study officials:
affiliation: UH Montpellier
name: Patrice Taourel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.