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

NCT ID: NCT06988007

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Whole body MRI in addition to the classic CT assessment for all participant.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Whole body MRI

Whole body MRI (ZTE sequence)

Group Type OTHER

Whole body MRI

Intervention Type DEVICE

Whole body MRI (ZTE sequence)

Interventions

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Whole body MRI

Whole body MRI (ZTE sequence)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of bone sarcoma with surgical indication

Exclusion Criteria

* Implanted material incompatible with MRI.
* Severe claustrophobia.
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Lecouvet

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Frédéric Lecouvet

Role: CONTACT

+3227642793

Perrine Triqueneaux

Role: CONTACT

Facility Contacts

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Frederic Emmanuel Lecouvet, MD PhD

Role: primary

+3227652793

Perrine Triqueneaux, Msc

Role: backup

027642935

Frédéric Lecouvet

Role: primary

+3227642793

Perrine Triqueneaux

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 35601663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24701131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26589726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30345471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29457287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11371335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31844960 (View on PubMed)

Other Identifiers

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2024/17DEC/563

Identifier Type: -

Identifier Source: org_study_id

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