Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction

Study Overview
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Brief Summary
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Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, the investigators created the personalized porous biodegradable scaffold and printed by 3D printer, using porous PCL biomaterials. During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection. Safety indicator, cosmetic outcome and autologous compatibility were evaluated.

Detailed Description
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3D image reconstruction and printing Magnetic model images data were firstly produced by Siemens Trio Tim 3. 0 T MRI. The relative scanning parameters were adjusted as follows: layer thickness 0.9mm; pixel pitch 0.625 mm. In general, the thicker the layer thickness and pixel pitch, the better resolution and the more similar reconstructed model the investigators will get. The MRI data were then imported into Mimics 17.0® [Materialise, Leuven, Belgium] for 3D reconstruction of the targeted area. In this software, the investigators can adjust threshold value to acclimatize to segment tumor area. After that, 3D models were calculated and output as .stl files. According to the requirements of surgical planning, the scope of tumor resection was created after 2 cm expansion of the tumor area, that is, the filling scope of the implant. Next, the investigators designed the personalized porous degradable scaffold. In order to guarantee no significant differences and deformation of the implanted scaffold, the investigators used the contour of tumor resection as the boundary of the scaffold, with flexible porous structure as the units of the scaffold. Boolean operation can help to achieve this target. Finally, the printing of the personalized porous biodegradable scaffold was carried out. Biologically active material PCL was selected and the deformation and degradation time were set for 2 years by adjusting the molecular weight of PCL. Theoretically, PCL with the molecular weight above 65,000 can stably exist for 2 years in vivo, and then it will gradually degrade into H2O and CO2.The PCL material was put into the 3D printer, which was developed by the State key laboratory for mechanical manufacturing systems engineering of Xi'an Jiaotong university. The personalized porous biodegradable scaffold was completed after printing and removing supports. Procedure In this study,the investigators produced the bio-implant at least 10 days before surgery. Before surgery, the printed bio-implant has been prepared and obtained full sterilization. Simply, under general anaesthesia, lumpectomy and sentinel-lymph-node biopsy was performed firstly, followed by 3D-printing scaffold transplantation.

Official Title
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Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction

Conditions
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Breast Reconstruction, Breast Cancer

Intervention / Treatment
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* Procedure: 3D printing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients Tumor sized 3 cm to 6 cm ECOG score 1-2 Multiple diffuse lesions in one quadrant Written informed consent Exclusion Criteria: Triple negative breast cancer patients Participant in another clinical study Pregnancy and breastfeeding Patients with nipple infringement Inflammatory breast carcinoma Paget's disease Serious operative contraindication Contraindication for MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printing patient<br>Immediate breast reconstruction using 3D printing personalized scaffold | Procedure: 3D printing<br>* Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, we created the personalized porous biodegradable scaffold and printed by 3D printer, using porous PCL biomaterials. During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Such adverse events include (but are not limited to) infection, repeated removal of implanted bio-scaffold, the humoral immunological responses. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | excellent (size and shape of reconstructed breast are identical to the original breast); good (deformity of the reconstructed breast involved less than 1/4 of the original breast; fair (deformity of the reconstructed breast involves less than 1/4-1/2 of the original breast); and poor (breast deformity involves more than 1/2 of the original breast). | 6 months after surgery | 
| Satisfaction of patients | The satisfaction of patients was investigated by self-made questionnaire | 6 months after surgery | 
| Recurrence rate | 5 year recurrence was observed | 5 year after surgery | 
| 5-Year disease free survival | 5 year survival was observed | 5 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biodegradable scaffold, immediate breast reconstruction, 3D printing