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3D Printed Implants for the Defect Reconstruction in Patients With Chest Wall Tumors

Primary Purpose

Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Implants
Plates
Sponsored by
Blokhin's Russian Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor of Bone focused on measuring Chest Wall Tumor, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Malignant neoplasm of ribs, sternum and clavicle
  • Malignant neoplasm of the connective and soft tissues of the chest
  • Neoplasm of uncertain or unknown nature of ribs, sternum and collarbone
  • Benign neoplasm of ribs, sternum and collarbone
  • Tumor lesions of the chest wall of any localization, malignant and benign, as well as of an uncertain or unknown nature
  • For malignant tumors: Grade 1-3
  • Lack of distant metastases
  • Signed informed consent

Exclusion Criteria:

  • Children, women during pregnancy, childbirth, women during breastfeeding.
  • Military personnel, with the exception of contract military personnel.
  • Persons with mental disorders.
  • Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
  • Patients with distant metastases (except for a solitary focus in the chest wall without other manifestations of the disease)
  • Inoperable tumor
  • The presence of another malignant tumor at the time of examination
  • ECOG 4
  • Having an active or chronic fungal / bacterial / viral infection
  • Uncontrolled chronic diseases of the liver, kidneys in the acute stage
  • Presence of metastases

Sites / Locations

  • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Replacement of a defect in the chest wall with an individual implant

Replacement of a defect in the chest wall with titanium plates

Arm Description

A patient with a tumor lesion of the chest wall undergoes СT scan with a step width of less than 1 mm, then engineers design an individual model to replace the defect. Using a 3D printer, a model is made based on the patient's anthropometric data.

The use of standard titanium plates to replace the chest defect. These plates must be modeled and modified using special equipment intraoperatively, based on the characteristics of the defect after resection.

Outcomes

Primary Outcome Measures

Disease-free survival
Time after treatment during which no sign of cancer is found

Secondary Outcome Measures

Comparison of hospitalization rate
Time after surgery till the end of hospitalization
Comparison of safety assessment
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Comparison of performance status according Karnofsky scale
Improvement on the Karnofsky scale by 10-30 points
Comparison of pain relief according Visual Analogue Scale
Improvement on the Visual Analogue Scale by 3-5 points
Comparison of pain relief according Whatkins scale
Improvement on the Whatkins scale by 1-2 points

Full Information

First Posted
September 7, 2021
Last Updated
March 1, 2022
Sponsor
Blokhin's Russian Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05057143
Brief Title
3D Printed Implants for the Defect Reconstruction in Patients With Chest Wall Tumors
Official Title
The Use of Individual 3D-implants in the Reconstruction of the Chest Wall in Patients With the Tumor Lesions of the Chest Wall for the Treatment, Restoration, and Improved Quality of Life Compared to Reconstruction With Titanium Plates
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blokhin's Russian Cancer Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A patient with a tumor lesion of the chest wall undergoes CT scan with a step width of less than 1 mm, then engineers design an individual model to replace the defect. Using a 3D printer, a model is made based on titanium alloy powder. Preoperative preparation takes an average of 14-21 days. The next stage is surgical treatment in the amount of resection of the chest wall with plastic defect with an individual titanium implant. In some cases, the titanium framework is separated from the pleural cavity by a polytetrafluoroethylene plate in order to seal and prevent the development of pulmonary hernias. The advantages of titanium individual prostheses include accurate matching of the implant to the size and characteristics of the defect, individual modeling allows you to repeat the anatomical features of the patient. This method helps to recreate the original shape of the chest, and most importantly, symmetrical, relatively healthy half. With the help of titanium, individualized prostheses are made based on 3D modeling, which will reduce the incidence of complications, accelerate rehabilitation and improve the quality of life of patients with tumor lesions of the chest wall. The postoperative period takes 15-30 days.
Detailed Description
A patient with a tumor lesion of the chest wall undergoes CT scan with a step width of less than 1 mm, then engineers design an individual model to replace the defect. Using a 3D printer, a model is made based on the patient's anthropometric data. Manufacturing takes place by 3D printing on a titanium alloy powder certified for the manufacture of medical implants. The technology used is a type of SLS (Selective Laser Sintering) -technology, layer-by-layer laser melting of metal-powder compositions. The printing process begins with dividing the digital 3D model of the product into layers with a thickness of 20 to 100 microns in order to create a 2D image of each layer of the product (section). The industry standard format is STL (Stereolithography) file. This file enters a special machine software, where the information is analyzed and compared with the technical capabilities of the machine. Based on the data obtained, a production cycle of construction is launched, consisting of many cycles of building individual layers of the product. The cycle for constructing a layer (section) consists of typical operations: applying a layer of powder of a given thickness to the construction plate; scanning by a laser beam of the section of the product layer. The laser beam is a source of heat, under the influence of which the particles of the material are sintered along the profile of the section of the model; lowering the platform into the depth of the construction well by an amount corresponding to the thickness of the construction layer. The process of building products takes place in the SLM (Selective Laser Melting) chamber of the machine, filled with an inert gas argon. After construction, the product is removed from the printer chamber and sent for heat treatment, annealing, to relieve internal stresses and improve mechanical properties. After annealing, the product is separated from the platform and undergoes finishing, which combines various types of machining. The final stages of the technological process are product cleaning and technical quality control. Preoperative preparation takes an average of 14-21 days. The next stage is surgical treatment in the amount of resection of the chest wall with plastic defect with an individual titanium implant. In all cases, the titanium framework is separated from the pleural cavity by a synthetic polyester (Dacron) plate in order to seal and prevent the development of pulmonary hernias. The advantages of titanium individual implants include accurate matching of the implant to the size and characteristics of the defect, individual modeling allows you to repeat the anatomical features of the patient. This method helps to recreate the original shape of the chest, and most importantly, symmetrical, relatively healthy half. With the help of titanium, individualized prostheses are made based on 3D modeling, which will reduce the incidence of complications, accelerate rehabilitation and improve the quality of life of patients with tumor lesions of the chest wall. The postoperative period takes 15-30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma, Sarcoma of Bone, Surgery, Implant Site Reaction
Keywords
Chest Wall Tumor, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Replacement of a defect in the chest wall with an individual implant
Arm Type
Experimental
Arm Description
A patient with a tumor lesion of the chest wall undergoes СT scan with a step width of less than 1 mm, then engineers design an individual model to replace the defect. Using a 3D printer, a model is made based on the patient's anthropometric data.
Arm Title
Replacement of a defect in the chest wall with titanium plates
Arm Type
Active Comparator
Arm Description
The use of standard titanium plates to replace the chest defect. These plates must be modeled and modified using special equipment intraoperatively, based on the characteristics of the defect after resection.
Intervention Type
Device
Intervention Name(s)
Implants
Intervention Description
3D printed implants
Intervention Type
Device
Intervention Name(s)
Plates
Intervention Description
Titanium plates
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Time after treatment during which no sign of cancer is found
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Comparison of hospitalization rate
Description
Time after surgery till the end of hospitalization
Time Frame
30 days
Title
Comparison of safety assessment
Description
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Time Frame
24 months
Title
Comparison of performance status according Karnofsky scale
Description
Improvement on the Karnofsky scale by 10-30 points
Time Frame
24 months
Title
Comparison of pain relief according Visual Analogue Scale
Description
Improvement on the Visual Analogue Scale by 3-5 points
Time Frame
24 months
Title
Comparison of pain relief according Whatkins scale
Description
Improvement on the Whatkins scale by 1-2 points
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Malignant neoplasm of ribs, sternum and clavicle Malignant neoplasm of the connective and soft tissues of the chest Neoplasm of uncertain or unknown nature of ribs, sternum and collarbone Benign neoplasm of ribs, sternum and collarbone Tumor lesions of the chest wall of any localization, malignant and benign, as well as of an uncertain or unknown nature For malignant tumors: Grade 1-3 Lack of distant metastases Signed informed consent Exclusion Criteria: Children, women during pregnancy, childbirth, women during breastfeeding. Military personnel, with the exception of contract military personnel. Persons with mental disorders. Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest. Patients with distant metastases (except for a solitary focus in the chest wall without other manifestations of the disease) Inoperable tumor The presence of another malignant tumor at the time of examination ECOG 4 Having an active or chronic fungal / bacterial / viral infection Uncontrolled chronic diseases of the liver, kidneys in the acute stage Presence of metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Salkov
Phone
+79629346738
Email
salkov1994@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslan Valiev, PhD
Organizational Affiliation
N.N. Blokhin NMRCO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pavel Kononets, PhD
Organizational Affiliation
N.N. Blokhin NMRCO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Salkov
Phone
+79629346738
Email
salkov1994@icloud.com
First Name & Middle Initial & Last Name & Degree
Aslan Valiev, PhD
First Name & Middle Initial & Last Name & Degree
Pavel Kononets, PhD
First Name & Middle Initial & Last Name & Degree
Teimuraz Charatishvili, PhD
First Name & Middle Initial & Last Name & Degree
Nikolay Petrochenko, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Salkov

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ronc.ru/about/struktura/niiko/ooo/hn1/
Description
official site
URL
https://sarcomarus.ru/
Description
russian surcoma group site

Learn more about this trial

3D Printed Implants for the Defect Reconstruction in Patients With Chest Wall Tumors

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