Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO) (REMASCO)
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Lille、法国、59020
- Centre Oscar Lambret
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immediate breast reconstruction
|
Functional MRI
|
|
实验性的：Secondary breast reconstruction
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Functional MRI
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
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.
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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.
大体时间：6 months
|
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.
大体时间：6 months
|
6 months
|
|
Topography variation in brain sensory projection area after total mastectomy and breast reconstruction.
大体时间：6 months
|
6 months
|
|
Satisfaction score and pre and postoperative quality-of-life score (Breast Q) according to a Likert scale.
大体时间：6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Claudia REGIS, MD、Centre Oscar Lambret
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- REMASCO-1503
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Functional MRI的临床试验
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)主动，不招人
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Memorial Sloan Kettering Cancer Center终止
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)终止