Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- postoperative cosmetic results and safety
研究概览
简要总结
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
详细描述
Study Objectives
- Primary Objective: To evaluate the clinical efficacy and safety of breast reconstruction using a 3D- printed biodegradable biological mesh.
- Secondary Objective: To evaluate the postoperative quality of life and breast cancer-free interval after breast reconstruction with a 3D-printed biodegradable biological mesh.
Treatment Plan
- Study Enrollment and Informed Consent: All subjects will sign the relevant informed consent forms before surgery.
- Preoperative Assessment: Patients will complete the Chinese version of the BREAST-Q V2.0 scale and the QoL (Quality of Life) scale.
- Preoperative Imaging Assessment:
Enrolled patients will undergo a preoperative thin-slice breast MRI (3.0T) using a multi-channel phased-array dedicated breast coil. The patient will be in a prone position, head-first. The operator will assist in placing the breast in the center of the coil, allowing it to hang naturally without compression to maintain its natural shape. The prone position also helps reduce respiratory motion artifacts. The patient's arms will be placed naturally in front of their head, avoiding the scan field to reduce artifacts. A high-pressure injector will be connected to an intravenous catheter. An axial three-dimensional thin- slice scan will be selected to display both breasts simultaneously, showing the radially arranged ducts converging towards the nipple and the glandular tissue in the axillary tail. The 3D thin-slice scan facilitates sagittal and coronal reconstructions. The scan range will cover the superior and inferior borders of both breasts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patients aged 18 to 70 years.
- •Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
- •Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
- •ECOG performance status of 0-
- •Voluntary participation in the study and signing of the written informed consent form.
排除标准
- •Age >70 years.
- •Metastatic breast cancer (Stage IV) at initial diagnosis.
- •Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
- •Tumor involvement of the nipple-areolar complex.
- •Breast cancer during pregnancy.
- •History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.
- •Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.
- •Patients deemed unsuitable for participation by the investigator.
研究组 & 干预措施
3D printing patient
immediate breast reconstruction using 3D-Printed Biodegradable Biological Mesh combined with a silicone breast prosthesis
干预措施: Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh (Procedure)
结局指标
主要结局
postoperative cosmetic results and safety
时间窗: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.
次要结局
- Recurrence-Free Survival (RFS)(At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.)
- Disease-Free Survival (DFS)(At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.)
- Overall Survival (OS)(At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.)
- Surgical Technical Safety (Complication Rate)(At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.)
研究者
Zhang Juliang-1
Associate Chief Physician
Xijing Hospital