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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00226-43 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
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Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.
The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.
Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to.
Immediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.
Secondary breast reconstruction group :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate breast reconstruction | Experimental |
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| Secondary breast reconstruction | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional MRI | Device | Functional MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the non-operated breast. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the breast reconstructed using an autologous flap and a prosthesis. | 6 months | |
| BOLD signal change (difference in intensity and anatomic location) in the regions activated during breast palpation between the reconstructed breast and the mastectomy scar before reconstruction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia REGIS, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 6 months |
| Topography variation in brain sensory projection area after total mastectomy and breast reconstruction. | 6 months |
| Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale. | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |