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

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ClinicalTrials.gov Identifier: NCT03348293
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Breast Cancer Procedure: 3D printing Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Cosmetic outcome [ Time Frame: 6 months after surgery ]
    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).

  2. Satisfaction of patients [ Time Frame: 6 months after surgery ]
    The satisfaction of patients was investigated by self-made questionnaire

  3. Recurrence rate [ Time Frame: 5 year after surgery ]
    5 year recurrence was observed

  4. 5-Year disease free survival [ Time Frame: 5 year after surgery ]
    5 year survival was observed



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348293


Contacts
Contact: Ju liang Zhang, Prof. 029-84775271 vascularzhang@163.com
Contact: Mei ling Huang, MD 029-84775271 huangmeiling@126.com

Locations
China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ju liang Zhang, Prof.    029-84775271    vascularzhang@63.com   
Sponsors and Collaborators
Xijing Hospital

Publications of Results:
Other Publications:
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03348293     History of Changes
Other Study ID Numbers: KY20172047-1
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:
biodegradable scaffold
immediate breast reconstruction
3D printing