Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, Or patient undergoing a unilateral secondary breast reconstruction
- •WHO performance status less than or equal to 2
- •Age ≥ 18 years
- •For patients of childbearing age, use of an effective contraceptive method for the duration of the study
- •Patient having been informed and having signed an informed consent form for the study.
排除标准
- •Patient undergoing a breast reconstruction by exclusive lipomodelling
- •Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves
- •Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards
- •History of brain surgery
- •History of contralateral breast surgery
- •History of prophylactic total mastectomy
- •Reconstruction techniques using a mixed procedure (autologous + prosthesis)
- •Patient on medication that may alter the BOLD signal in MRI
- •Pregnant or breastfeeding women
- •Patient under tutorship or guardianship
研究组 & 干预措施
Immediate breast reconstruction
- Total mastectomy + immediate reconstructive surgery
- 6 months after surgery : Functional MRI and questionnaires
干预措施: Functional MRI (Device)
Secondary breast reconstruction
- Within 2 months before surgery : Functional MRI
- Reconstructive surgery
- 6 months after surgery : Functional MRI and questionnaires
干预措施: Functional MRI (Device)
结局指标
主要结局
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.
时间窗: 6 months
次要结局
- Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.(6 months)
- 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.(6 months)
- Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.(6 months)