A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative cosmetic effects and quality of life
研究概览
简要总结
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is:
Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction?
Participants will:
Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.
详细描述
This is a prospective, multicenter, controlled clinical study divided into three groups. The experimental group receives breast reconstruction using 3D-printed biodegradable material breast implants, while the control groups undergo traditional breast-conserving surgery or breast reconstruction with silicone implants.
After providing full informed consent, subjects voluntarily choose their surgical approach, sign the informed consent form, and enter the trial period after passing screening. The specific treatment protocols are as follows:
- Preoperative Patient-Reported Outcome Assessment:
The Chinese version of the BREAST-Q V2.0 scale is used to evaluate breast aesthetics, satisfaction, and quality of life, with calculation of the Q-score. 2. Imaging Assessment:
Enrolled patients undergo preoperative thin-slice breast magnetic resonance imaging (MRI), including conventional plain scan (SE T1WI sequence) and 3D dynamic contrast-enhanced scanning (FLASH sequence) to obtain three-dimensional enhanced images. 3. Surgical Simulation, Design, and 3D Printing of Fillers for the Experimental Group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
- •Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
- •Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
- •ECOG performance status score: 0-
- •If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
- •Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.
排除标准
- •Age > 70 years.
- •Newly diagnosed stage IV metastatic breast cancer.
- •Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
- •Tumor invasion of the papillary areola complex.
- •Inability to accept/tolerate radiotherapy.
- •Breast cancer during pregnancy.
- •History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
- •Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
- •Patients deemed unsuitable for participation by the researchers.
结局指标
主要结局
Postoperative cosmetic effects and quality of life
时间窗: One year after the operation
Patient satisfaction in the reconstruction module of the BREAST-Q scale is used for scoring, including: satisfaction with the breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score is the main endpoint of this study. After the BREAST-Q questionnaire is completed, its score is calculated and called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score, and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial, and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.
次要结局
- Recurrence-free survival (RFS)(Three months, half a year, one year after the operation, and then once a year thereafter until ten years)
- Disease-free survival (DFS)(Three months, half a year, one year after the operation, and then once a year thereafter until ten years)
- Overall survival (OS)(Three months, half a year, one year after the operation, and then once a year thereafter until ten years)
- Surgical technique safety (incidence of complications)(Immediately after the operation, and at 3 days, 7 days, 10 days, 14 days, 1 month, 3 months, 6 months, 12 months and 24 months after the operation)