UnknownNot Applicable

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

Russia30 participantsStarted 2022-01-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease-free survival

Timeframe: 24 months

Trial details

NCT IDNCT05057143

SponsorBlokhin's Russian Cancer Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Alexander Salkov

+79629346738 salkov1994@icloud.com

View on ClinicalTrials.gov More Tumor of Bone trials