Interest of Self-compression Technique on Tolerance of Mammography

Breast Cancer Clinical Trial

— ITACTs  

Official title:

Interest of Self-compression Technique on Tolerance of Mammography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866591
• Other study ID #: 2012-A00248-35
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• mammography according to an auto-compression procedure

• mammography according to a standard procedure

• questionary

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography	The comparison will be evaluated by the thickness (mm) of breast compressed	1 day
Secondary	Overall tolerance of mammography	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.	1 day
Secondary	Breast compression force	Value measured on compressive force console (Newtons)	1 day
Secondary	Thickness / compressing force ratio		1 day
Secondary	Image quality	The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale	1 day
Secondary	Overall assessment of the manipulator	The appreciation of the manipulator will be assessed using a 4-point scale	1 day
Secondary	Overall assessment of self-satisfaction of the patient at the end of the examination	The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)	1 day