SarcomaSARCOUPENCT06988007
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
A study testing Whole body MRI in people with Sarcoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Whole body MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bone sarcoma with surgical indication
Who cannot join
- Implanted material incompatible with MRI.
- Severe claustrophobia.
- Pregnant women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Perrine Triqueneaux contact
Belgium2 sites
Cliniques Universitaires Saint Luc
Brussels
Frederic Emmanuel Lecouvet, MD PhD, +3227652793, frederic.lecouvet@saintluc.uclouvain.be
Perrine Triqueneaux, Msc, 027642935, perrine.triqueneaux@saintluc.uclouvain.be
Cliniques universitaires Saint-Luc
Brussels
Frédéric Lecouvet, +3227642793, frederic.lecouvet@saintluc.uclouvain.be
Perrine Triqueneaux, perrine.triqueneaux@saintluc.uclouvain.be
About this study
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- Whole body MRI
- Keywords
- Imaging, sarcoma, cutting guide, MRI
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body MRIDevice
Whole body MRI (ZTE sequence)
| Study group | Role | What they receive |
|---|---|---|
| Whole body MRI | Other | Whole body MRI (ZTE sequence) Receives: Device: Whole body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Whole body MRI in addition to the classic CT assessment for all participant.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Lecouvet, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988007
- Sponsor's protocol ID
- 2024/17DEC/563
- Acronym
- SARCOUPE
- Status last verified
- Apr 2026
- First submitted
- 15 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethic reason
Publications
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.
PubMed 35601663Bellanova 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.
PubMed 24701131Cobben 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.
PubMed 26589726Sousa 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.
PubMed 30345471Wiesinger 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.
PubMed 29457287Lecouvet 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.
PubMed 11371335Lecouvet 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.
PubMed 31844960
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06988007
- Acronym / sponsor ID
- SARCOUPE / 2024/17DEC/563
- Conditions
- Sarcoma
- Keywords
- Imaging, sarcoma, cutting guide, MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Whole body MRI in addition to the classic CT assessment for all participant.
| Arm | Type | Receives |
|---|---|---|
| Whole body MRI | Other | Device: Whole body MRIWhole body MRI (ZTE sequence) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of bone sarcoma with surgical indication
Key exclusion criteria (3 listed)
- Implanted material incompatible with MRI.
- Severe claustrophobia.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body MRIWhole body MRI (ZTE sequence) | Device | Whole body MRI |
Primary outcome
Evaluation of the absolute error of surgical margins
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 35601663Evrard 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.
- Background: PubMed 24701131Bellanova 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.
- Background: PubMed 26589726Cobben 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.
- Background: PubMed 30345471Sousa 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.
- Background: PubMed 29457287Wiesinger 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.
- Background: PubMed 11371335Lecouvet 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.
- Background: PubMed 31844960Lecouvet 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.
- Individual participant dataSharing planned: No. Ethic reason
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Perrine Triqueneaux contact
Frédéric Lecouvet principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body MRI in people with Sarcoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Lecouvet (+3227642793, frederic.lecouvet@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the absolute error of surgical margins (time frame: through study completion, an average of year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988007, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.