Clinical trial NCT06988007: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcoma
Keywords: Imaging
sarcoma
cutting guide
MRI
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Whole body MRI in addition to the classic CT assessment for all participant.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of bone sarcoma with surgical indication

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of the absolute error of surgical margins
timeFrame: through study completion, an average of year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Frédéric Lecouvet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.