Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Breast Cancer Clinical Trial

— TOMOSEIN  

Official title:

Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612650
• Other study ID #: TOMOSEIN-1104
• Secondary ID: 2011-002051-34
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: March 21, 2018
• Start date: February 24, 2012
• Est. completion date: March 16, 2017

Study information

• Verified date: March 2018
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1069
• Est. completion date: March 16, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly

• age = 40 years (group 1, group 2); age = 50 years (group 3)

• breast size suitable for detector size

• possible prior mastectomy

• security social covered

• signed informed consent

Exclusion Criteria:

• breast implant

• high genetic risk (mutation)

• under justice measures

• breast feeding or pregnant woman

Related Conditions & MeSH terms

• 2D Mammography
• 3D Mammography
• Breast Cancer

Intervention

Device:
• tomosynthesis
2 incidences 3D numeric mammography
• 2D mammography
2 incidences 2D analogic mammography

Locations

Country	Name	City	State
France	Oscar Lambret Center	Lille
France	Centre Hospitalier - Pavillon Paul Gelé	Roubaix
France	Centre Hospitalier	Valenciennes
France	Clinique des Dentellières	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the benefit of tomosynthesis for diagnosis	number of avoided focused cliches and ultrasound, after tomosynthesis analysis	30 months
Secondary	determine best incidence of realization	face, medial side or oblique	30 months
Secondary	measurement of breast irradiation	comparison of tomosynthesis irradiation and focused cliches irradiation	30 months
Secondary	evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast		30 months
Secondary	number of additional cancer detected by tomosynthesis	number of breast cancer detected through tomosynthesis	30 months