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OpenTrials
Completed

NCT Number: NCT01612650

Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

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

Completed

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Key information

Conditions

Breast Cancer 2D Mammography 3D Mammography Breast Diseases Breast Neoplasms Disease Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oscar Lambret Center, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tomosynthesis

Device

2 incidences 3D numeric mammography

2D mammography

Device

2 incidences 2D analogic mammography

Primary outcomes

  1. determine the benefit of tomosynthesis for diagnosis

    Time frame: 30 months

    number of avoided focused cliches and ultrasound, after tomosynthesis analysis

Secondary outcomes

  1. determine best incidence of realization

    Time frame: 30 months

    face, medial side or oblique

  2. measurement of breast irradiation

    Time frame: 30 months

    comparison of tomosynthesis irradiation and focused cliches irradiation

  3. evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast

    Time frame: 30 months

  4. number of additional cancer detected by tomosynthesis

    Time frame: 30 months

    number of breast cancer detected through tomosynthesis

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Acronym: TOMOSEIN

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2012
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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