3D Printing in Breast Reconstruction: From Bench to Bed.
Xingdou Mu, Juliang Zhang, Yue Jiang
https://pubmed.ncbi.nlm.nih.gov/34095200Actively Recruiting
Phase 2
Age: 18Years - 70Years
FEMALE
ID06993714
A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration
Led by Xijing Hospital · Updated on 2025-06-06
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the cosmetic outcomes and quality of life for breast cancer patients undergoing breast reconstruction using 3D-printed biodegradable material breast implants. This study compares these results with traditional breast-conserving surgery and traditional silicone prosthesis breast reconstruction. It also explores the safety and potential medical issues related to using 3D-printed biodegradable implants for breast reconstruction in patients not suitable for breast-conserving surgery. Participants are divided into three groups: one group receives breast reconstruction using 3D-printed biodegradable implants, the second undergoes traditional breast-conserving surgery, and the third has traditional silicone prosthesis breast reconstruction. The trial includes preoperative assessments, imaging with MRI, surgical planning with 3D printing of implants for the experimental group, and surgery according to each group's procedures. Postoperative care includes wound management, systemic therapies such as chemotherapy or endocrine therapy, and radiotherapy based on clinical guidelines. During the study, participants undergo regular follow-up with breast ultrasounds weekly for the first month and monthly thereafter, MRI scans at 3, 6, 12, and 24 months, and patient-reported outcome assessments using the BREAST-Q V2.0 scale to evaluate breast aesthetics, satisfaction, and quality of life. Telephone follow-ups occur monthly, with in-person visits every three months. The primary outcome measured is cosmetic effects and quality of life one year after surgery, alongside safety and long-term survival outcomes up to ten years.
CONDITIONS
Brief Title
3D-printed Biodegradable Breast Implants for Breast Restoration
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 of 0-1.
- 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.
You will not qualify if you...
- Age over 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 or 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo breast surgery according to their chosen group: 3D-printed biodegradable implant breast reconstruction, traditional breast-conserving surgery, or traditional silicone prosthesis breast reconstruction. Surgery includes tumor resection and may involve lymph node procedures.
1 visit (in-person)
Postoperative Follow-up
Duration - Up to 1 month
Participants receive wound care with scheduled dressing changes and monitoring for complications. Systemic therapies such as chemotherapy, endocrine therapy, and radiotherapy are administered as clinically indicated.
Weekly visits for the first month post-surgery
Postoperative Monitoring
Duration - Up to 24 months
Participants undergo routine breast ultrasound weekly for the first postoperative month, then monthly to assess changes in the filler area. Full-volume breast ultrasounds are performed every 3 months to monitor recovery and implant status.
Weekly visits for 1 month, then monthly visits, and ultrasound every 3 months
Imaging and Patient-Reported Outcome Assessments
Duration - Over 24 months
Participants have breast MRI scans and complete quality of life and satisfaction questionnaires at 3, 6, 12, and 24 months after surgery to evaluate cosmetic effects and wellbeing.
4 visits (in-person) at 3, 6, 12, and 24 months post-surgery
Telephone and In-Person Follow-Up
Duration - Up to 10 years
Participants receive monthly telephone follow-ups and in-person visits every 3 months to monitor health status and disease recurrence.
Monthly phone calls and in-person visits every 3 months
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
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Research Team
J
Ju liang J L Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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