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Completed

NCT Number: NCT02866591

Interest of Self-compression Technique on Tolerance of Mammography

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients ≥ 18 years and ≤ 75 years of age
  • ECOG performance <2
  • Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion criteria

  • Eastern Cooperative Oncology Group performance status ≥ 2
  • Treatment for benign lesion with surgery for less than 3 years
  • Treatment for cancer with surgery and / or radiotherapy for less than 3 years
  • Biopsy for less than 1 year
  • Breast prosthesis
  • Mastectomy
  • Assessment motivated by a clinical breast abnormality

Treatment and study plan

mammography according to an auto-compression procedure

Other

mammography according to a standard procedure

Other

questionary

Other

Primary outcomes

  1. Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography

    Time frame: 1 day

    The comparison will be evaluated by the thickness (mm) of breast compressed

Secondary outcomes

  1. Overall tolerance of mammography

    Time frame: 1 day

    The overall tolerance of mammography will be assessed by the patient after 4 shots. The pain felt by the patient will be assessed using a visual analog scale.

  2. Breast compression force

    Time frame: 1 day

    Value measured on compressive force console (Newtons)

  3. Thickness / compressing force ratio

    Time frame: 1 day

  4. Image quality

    Time frame: 1 day

    The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale

  5. Overall assessment of the manipulator

    Time frame: 1 day

    The appreciation of the manipulator will be assessed using a 4-point scale

  6. Overall assessment of self-satisfaction of the patient at the end of the examination

    Time frame: 1 day

    The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: ITACTs

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2016
Registry last updated
Aug 8, 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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