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

NCT06988007 | Not Yet Recruiting

• 1 other identifier: 2024/17DEC/563
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcoma

Keywords

Imaging; sarcoma; cutting guide; MRI

Outcome Measures

Primary Outcomes (1)

• Evaluation of the absolute error of surgical margins

  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.

  through study completion, an average of year

Study Arms (1)

Whole body MRI

OTHER

Whole body MRI (ZTE sequence)

Device: Whole body MRI

Interventions

Whole body MRI DEVICE

Whole body MRI (ZTE sequence)

Whole body MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of bone sarcoma with surgical indication

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

Related Publications (7)

• Evrard R, Schubert T, Paul L, Docquier PL. Quality of resection margin with patient specific instrument for bone tumor resection. J Bone Oncol. 2022 May 13;34:100434. doi: 10.1016/j.jbo.2022.100434. eCollection 2022 Jun.

  PMID: 35601663 BACKGROUND

• Bellanova L, Schubert T, Cartiaux O, Lecouvet F, Galant C, Banse X, Docquier PL. MRI-Based Assessment of Safe Margins in Tumor Surgery. Sarcoma. 2014;2014:686790. doi: 10.1155/2014/686790. Epub 2014 Feb 20.

  PMID: 24701131 BACKGROUND

• Cobben DC, de Boer HC, Tijssen RH, Rutten EG, van Vulpen M, Peerlings J, Troost EG, Hoffmann AL, van Lier AL. Emerging Role of MRI for Radiation Treatment Planning in Lung Cancer. Technol Cancer Res Treat. 2016 Dec;15(6):NP47-NP60. doi: 10.1177/1533034615615249. Epub 2015 Nov 19.

  PMID: 26589726 BACKGROUND

• Sousa JM, Appel L, Engstrom M, Papadimitriou S, Nyholm D, Larsson EM, Ahlstrom H, Lubberink M. Evaluation of zero-echo-time attenuation correction for integrated PET/MR brain imaging-comparison to head atlas and 68Ge-transmission-based attenuation correction. EJNMMI Phys. 2018 Oct 22;5(1):20. doi: 10.1186/s40658-018-0220-0.

  PMID: 30345471 BACKGROUND

• Wiesinger F, Bylund M, Yang J, Kaushik S, Shanbhag D, Ahn S, Jonsson JH, Lundman JA, Hope T, Nyholm T, Larson P, Cozzini C. Zero TE-based pseudo-CT image conversion in the head and its application in PET/MR attenuation correction and MR-guided radiation therapy planning. Magn Reson Med. 2018 Oct;80(4):1440-1451. doi: 10.1002/mrm.27134. Epub 2018 Feb 18.

  PMID: 29457287 BACKGROUND

• Lecouvet FE, Vande Berg BC, Malghem J, Maldague BE. Magnetic resonance and computed tomography imaging in multiple myeloma. Semin Musculoskelet Radiol. 2001;5(1):43-55. doi: 10.1055/s-2001-12920.

  PMID: 11371335 BACKGROUND

• Lecouvet FE, Boyadzhiev D, Collette L, Berckmans M, Michoux N, Triqueneaux P, Pasoglou V, Jamar F, Vekemans MC. MRI versus 18F-FDG-PET/CT for detecting bone marrow involvement in multiple myeloma: diagnostic performance and clinical relevance. Eur Radiol. 2020 Apr;30(4):1927-1937. doi: 10.1007/s00330-019-06469-1. Epub 2019 Dec 16.

  PMID: 31844960 BACKGROUND

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Frédéric Lecouvet

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Lecouvet

CONTACT

+3227642793; frederic.lecouvet@saintluc.uclouvain.be

Perrine Triqueneaux

CONTACT

perrine.triqueneaux@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Whole body MRI in addition to the classic CT assessment for all participant.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)