Interest of Self-compression Technique on Tolerance of Mammography

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02866591
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography	1 day	The comparison will be evaluated by the thickness (mm) of breast compressed

Secondary Outcome Measures

Name	Time	Method
Overall assessment of self-satisfaction of the patient at the end of the examination	1 day	The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)
Thickness / compressing force ratio	1 day
Overall tolerance of mammography	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.
Breast compression force	1 day	Value measured on compressive force console (Newtons)
Image quality	1 day	The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale
Overall assessment of the manipulator	1 day	The appreciation of the manipulator will be assessed using a 4-point scale

Trial Locations

Locations (6)

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre François Baclesse; 🇫🇷 Caen, France

Cabinet de radiologie; 🇫🇷 Nancy, France

Polyclinique Majorelle; 🇫🇷 Nancy, France

Institut Curie; 🇫🇷 Paris, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-Nancy, France