Interest of Self-compression Technique on Tolerance of Mammography (ITACTs)
|ClinicalTrials.gov Identifier: NCT02866591|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: mammography according to an auto-compression procedure Other: mammography according to a standard procedure Other: questionary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Interest of Self-compression Technique on Tolerance of Mammography|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Arm A
Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.
Other: mammography according to an auto-compression procedure
Active Comparator: Arm B
Patients have a mammography performed by the radiologist according to standard procedure.
Other: mammography according to a standard procedure
- 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
- 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.
- Breast compression force [ Time Frame: 1 day ]Value measured on compressive force console (Newtons)
- Thickness / compressing force ratio [ Time Frame: 1 day ]
- 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
- Overall assessment of the manipulator [ Time Frame: 1 day ]The appreciation of the manipulator will be assessed using a 4-point scale
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866591
|Bordeaux, France, 33000|
|Centre François Baclesse|
|Caen, France, 14076|
|Cabinet de radiologie|
|Nancy, France, 54000|
|Nancy, France, 54000|
|Paris, France, 75248|
|Institut de Cancérologie de Lorraine|
|Vandoeuvre-les-Nancy, France, 54519|
|Principal Investigator:||HENROT Philippe, MD||Institut de Cancérologie de Lorraine|