Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Breast Cancer Clinical Trial

Official title:

Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01881880
• Other study ID #: 8904
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2013
• Last updated: January 8, 2015
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: University Hospital, Montpellier
• Contact: Patrice Taourel
• Phone: +33 467338601
• Email: p-taourel[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Bilateral mammography with Tomosynthesis
no intervention pre specified to be administered to participants

Locations

Country	Name	City	State
France	Private Hospital oh Antony	Antony
France	UH Grenoble	Grenoble
France	Oscar Lambret Center	Lille
France	Jean Mermoz Hospital	Lyon
France	UH Montpellier	Montpellier
France	Hospital Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity	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	No
Secondary	performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality	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	No