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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Reconstruction
• Intervention / Treatment: Procedure: 3D printing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ju liang Zhang, Prof.; Phone Number: 029-84775271; Email: vascularzhang@163.com
• Study Contact Backup: Name: Mei Ling Huang, MD; Phone Number: 029-84775271; Email: huangmeiling@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Ju liang Zhang, Prof.; Phone Number: 029-84775271; Email: vascularzhang@63.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D printing patient; Immediate breast reconstruction using 3D printing personalized scaffold	Procedure: 3D printing; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Publications and helpful links

General Publications

• The utility of 3D printing for surgical planning and patient-specific implant design for complex spinal pathologies: case report. J Neurosurg Spine. 2017 Apr;26(4):513-518. doi: 10.3171/2016.9.SPINE16371. Epub 2017 Jan 20.
• Chia HN, Wu BM. Recent advances in 3D printing of biomaterials. J Biol Eng. 2015 Mar 1;9:4. doi: 10.1186/s13036-015-0001-4. eCollection 2015.
• Ibrahim AM, Jose RR, Rabie AN, Gerstle TL, Lee BT, Lin SJ. Three-dimensional Printing in Developing Countries. Plast Reconstr Surg Glob Open. 2015 Aug 10;3(7):e443. doi: 10.1097/GOX.0000000000000298. eCollection 2015 Jul.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: immediate breast reconstruction; 3D printing; biodegradable scaffold
• Other Study ID Numbers: KY20172047-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No