Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02553967
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
Official Title:
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMASCO
Brief Summary:
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.
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.
Detailed Description:
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 :
* In the two months preceding the surgery, a preoperative fMRI will be performed.
* 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.
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 :
* In the two months preceding the surgery, a preoperative fMRI will be performed.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: