Bone Arches: Performance of Pseudo-scanner Sequences in Segmenting the Extent of the Tumour and in Planning Surgical Resection Using the CT Scan as a Reference

Not Applicable

Not yet recruiting

• Conditions: Sarcoma

• Registration Number: NCT06988007
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The goal of this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

Detailed Description

The management of bone sarcomas is complex, and imaging plays an important role in both diagnosis and treatment monitoring. MRI is the method of choice to provide accurate information on the extent of the bone tumor and its relationship to adjacent soft tissues. However, an additional CT scan is routinely performed and combined with MRI images (spatial realignment) using software and relying on manual control and/or correction. This is essential during surgical planning to i) ensure resection with properly defined safety margins and ii) allow for accurate bone reconstruction.ing.

This exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-07-01
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• diagnosis of bone sarcoma with surgical indication

Exclusion Criteria

• Implanted material incompatible with MRI.
• Severe claustrophobia.
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the absolute error of surgical margins	through study completion, an average of year	The error values observed in the study by Cartiaux et al. to assess the reduction in absolute error of surgical margins obtained when using a computer-assisted cutting procedure (using 3DSide software installed on a laptop belonging to 3Dside, made available to the doctoral student) compared to freehand cutting are used to size the present study. The objective is to compare the absolute error resulting from a cutting procedure assisted by this 3DSide software based on "pseudo-scanner" imaging with that resulting from the same procedure based on standard scanner imaging.

Trial Locations

Locations (2)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium