3D printed implants for chest wall tumor reconstruction

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

This study is testing if custom 3D printed titanium implants can help patients with chest wall tumors recover better after surgery by restoring the shape and look of their chest.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Blokhin's Russian Cancer Research Center (other)
• Locations: 1 site (Moscow)
• Trial ID: NCT05057143 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients with chest wall tumors who require surgical reconstruction. It utilizes advanced 3D printing technology to create individualized titanium implants based on detailed CT scans of the patient's anatomy. The process involves designing a model that accurately matches the defect, followed by a surgical procedure to implant the custom prosthesis. This innovative approach aims to restore the original shape and symmetry of the chest wall, enhancing both functionality and aesthetics.

Who should consider this trial

Good fit: Ideal candidates include individuals with malignant or benign tumors of the chest wall, specifically those without distant metastases.

Not a fit: Patients with inoperable tumors, distant metastases, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could significantly improve surgical outcomes and quality of life for patients with chest wall tumors.

How similar studies have performed: While the use of 3D printed implants is gaining traction, this specific application for chest wall tumors is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Moscow

• Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation — Moscow, Russian Federation (RECRUITING)

Study contacts

• Principal investigator: Aslan Valiev, PhD — N.N. Blokhin NMRCO
• Study coordinator: Alexander Salkov

Conditions: Tumor of Bone, Chest Wall Tumor, Chest Wall Sarcoma, Sarcoma of Bone, Surgery, Implant Site Reaction