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

NCT03348293 | Completed Phase 1

• 1 other identifier: KY20172047-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Breast Cancer

Keywords

biodegradable scaffold; immediate breast reconstruction; 3D printing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cosmetic outcome

  6 months after surgery

• Satisfaction of patients

  6 months after surgery

• Recurrence rate

  5 year after surgery

• 5-Year disease free survival

  5 year after surgery

Study Arms (1)

3D printing patient

EXPERIMENTAL

Immediate breast reconstruction using 3D printing personalized scaffold

Procedure: 3D printing

Interventions

3D printing PROCEDURE

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.

3D printing patient

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Breast cancer patients
• Tumor sized 3 cm to 6 cm
• ECOG score 1-2
• Multiple diffuse lesions in one quadrant
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

• 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.

  PMID: 25866560 BACKGROUND

• 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.

  PMID: 26301132 BACKGROUND

• 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.

  PMID: 28106524 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Printing, Three-Dimensional

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: November 20, 2017
• Study Start: July 30, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-05

Locations

CN (1)