Tumor of BoneNCT05057143
3D Printed Implants for the Defect Reconstruction in Patients With Chest Wall Tumors
A study testing Implants and Plates in people with Tumor of Bone and Chest Wall Tumor, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma
- What is being tested?
- Implants and Plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow, 115478
Alexander Salkov, +79629346738, salkov1994@icloud.com
Aslan Valiev, PhD
About this study
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
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.
Read the 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.
- Conditions
- Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma, Sarcoma of Bone, Surgery, Implant Site Reaction
- Being tested
- Implants, Plates
- Keywords
- Chest Wall Tumor, Surgery
- Medical subject headings
- Bone Neoplasms, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantsDevice
3D printed implants
PlatesDevice
Titanium plates
| Study group | Role | What they receive |
|---|---|---|
| Replacement of a defect in the chest wall with an individual implant | Experimental | 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. Receives: Device: Implants |
| Replacement of a defect in the chest wall with titanium plates | Active comparator | 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. Receives: Device: Plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Time after treatment during which no sign of cancer is found
Measured: 24 months
Secondary outcomes (5)
Comparison of hospitalization rate
Time after surgery till the end of hospitalization
Measured: 30 days
Comparison of safety assessment
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Measured: 24 months
Comparison of performance status according Karnofsky scale
Improvement on the Karnofsky scale by 10-30 points
Measured: 24 months
Comparison of pain relief according Visual Analogue Scale
Improvement on the Visual Analogue Scale by 3-5 points
Measured: 24 months
Comparison of pain relief according Whatkins scale
Improvement on the Whatkins scale by 1-2 points
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start10 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslan Valiev, PhD, Principal investigator, N.N. Blokhin NMRCOPavel Kononets, PhD, Principal investigator, N.N. Blokhin NMRCO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057143
- Sponsor's protocol ID
- CWP-2021-7-3
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2021
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05057143
- Acronym / sponsor ID
- CWP-2021-7-3
- Conditions
- Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma, Sarcoma of Bone, Surgery, Implant Site Reaction
- Keywords
- Chest Wall Tumor, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replacement of a defect in the chest wall with an individual implant | Experimental | Device: ImplantsA 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. |
| Replacement of a defect in the chest wall with titanium plates | Active comparator | Device: PlatesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implants3D printed implants | Device | Replacement of a defect in the chest wall with an individual implant |
| PlatesTitanium plates | Device | Replacement of a defect in the chest wall with titanium plates |
Primary outcome
Disease-free survival
Time frame: 24 months
Time after treatment during which no sign of cancer is found
5 secondary outcomes
Comparison of hospitalization rate
Time frame: 30 days
Comparison of safety assessment
Time frame: 24 months
Comparison of performance status according Karnofsky scale
Time frame: 24 months
Comparison of pain relief according Visual Analogue Scale
Time frame: 24 months
Comparison of pain relief according Whatkins scale
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- official siteLink provided by the sponsor.
- russian surcoma group siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslan Valiev, PhD principal investigator
N.N. Blokhin NMRCO
Pavel Kononets, PhD principal investigator
N.N. Blokhin NMRCO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implants and Plates in people with Tumor of Bone and Chest Wall Tumor, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Salkov (+79629346738, salkov1994@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.