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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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. |
|
| Arm B | Active Comparator | Patients have a mammography performed by the radiologist according to standard procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mammography according to an auto-compression procedure | Other |
| ||
| mammography according to a standard procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Breast compression force |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HENROT Philippe, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33000 | France | |||
| Centre François Baclesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30715083 | Derived | Henrot P, Boisserie-Lacroix M, Boute V, Troufleau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Other |
|
| questionary | Other |
|
Value measured on compressive force console (Newtons)
| 1 day |
| Thickness / compressing force ratio | 1 day |
| Image quality | The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale | 1 day |
| Overall assessment of the manipulator | The appreciation of the manipulator will be assessed using a 4-point scale | 1 day |
| 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 |
| Caen |
| 14076 |
| France |
| Cabinet de radiologie | Nancy | 54000 | France |
| Polyclinique Majorelle | Nancy | 54000 | France |
| Institut Curie | Paris | 75248 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |