Bone TumorTUMOSTEONCT02895633
Osteoarticular Tumor Characterization by Advanced Imaging
A study testing Ecography, CT scan and MRI in people with Bone Tumor and Soft Tissue Tumor, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Tumor, Soft Tissue Tumor
- What is being tested?
- Ecography, CT scan and MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,090 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
- patients with normal awareness level
- patients having signed informed consent
Who cannot join
- pregnant women
- persons deprived of liberty
- persons under legal protection or unable to give informed consent
- persons in life-threatening emergency
- allergy to Sonovue, iodinated contrast media or gadolinium chelates
- risk of pregnancy
Show all 10Show fewer
- breastfeeding women
- acute coronary syndrome or unstable ischemic cardiopathy (ban on injection of contrast agent for CT scan)
- renal failure (ban on injection of contrast agent for MRI and CT scan)
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
Pedro Augusto GONDIM TEIXEIRA contact
France1 site, 1 recruiting
- Recruiting
Service d'Imagerie Guilloz, CHRU Nancy
Nancy
About this study
The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.
Secondary purposes are:
Read more
- to determine a possible correlation between some parameters and the histological grade (FNCLCC)
- to suggest a coherent diagnostic imaging approach for osteoarticular tumors.
The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.
Read the detailed description
Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.
Histologic analysis will be used as a gold standard.
The following imaging techniques will be evaluated:
- contrast enhanced ultrasonography
- Low dose CT perfusion
- Magnetic resonance perfusion
- Diffusion weighted imaging
- Magnetic resonance proton spectroscopy
- Conditions
- Bone Tumor, Soft Tissue Tumor
- Being tested
- Ecography, CT scan, MRI
- Keywords
- MR imaging, Diffusion weighted imaging, MR proton spectroscopy, CT perfusion, Contrast enhanced ultrasound
- Medical subject headings
- Bone Neoplasms, Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcographyOther
Standard Doppler ultrasound and perfusion imaging after injection of Sonovue
CT scanOther
With injection of Iomeron 400
MRIOther
With injection of gadolinium (Multihance)
| Study group | Role | What they receive |
|---|---|---|
| Patients with bone or peripheral soft-tissue tumor | Experimental | Not described Receives: Other: Ecography; Other: CT scan; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement in echography: yes or no
Measured: baseline
Contrast enhancement curve (absent, slow or fast) in echography
Measured: baseline
Maximal intensity of enhancement peak in echography
Measured: baseline
Mean transit time of enhancement in echography
Measured: baseline
Gradient of contrast enhancement curve in echography
Measured: baseline
Vascularization (dynamic analysis) in CT scanner
- 0: absent
- 1: low (< 20UH)
- 2: > 20 UH without new blood vessels
- 3: > 20 UH and/or with new blood vessels
Measured: baseline
Contrast enhancement curve (absent, slow or fast) in CT scanner
Measured: baseline
Maximal intensity of enhancement peak in CT scanner
Measured: baseline
Mean transit time of enhancement in CT scanner
Measured: baseline
Gradient of contrast enhancement curve in CT scanner
Measured: baseline
Contrast enhancement curve (absent, slow or fast) in MRI
Measured: baseline
Maximal intensity of enhancement peak in MRI
Measured: baseline
Mean transit time of enhancement in MRI
Measured: baseline
Gradient of contrast enhancement curve in MRI
Measured: baseline
Choline peak in magnetic resonance spectroscopy
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Measured: baseline
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
ADC value in mm2/s
Measured: baseline
Area under the perfusion curve in MRI
Measured: baseline
Perfusion curve gradient in MRI
Measured: baseline
Perfusion time-to-peak in MRI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startNov 2009
- Primary completionNov 2018 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Augusto GONDIM TEIXEIRA, Principal investigator, Service d'Imagerie Guilloz, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895633
- Sponsor's protocol ID
- 2009-A00758-49
- Acronym
- TUMOSTEO
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.
PubMed 33765161
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarticular Tumor Characterization by Advanced Imaging
- ClinicalTrials.gov ID
- NCT02895633
- Acronym / sponsor ID
- TUMOSTEO / 2009-A00758-49
- Conditions
- Bone Tumor, Soft Tissue Tumor
- Keywords
- MR imaging, Diffusion weighted imaging, MR proton spectroscopy, CT perfusion, Contrast enhanced ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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 purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.
Secondary purposes are:
- to determine a possible correlation between some parameters and the histological grade (FNCLCC)
- to suggest a coherent diagnostic imaging approach for osteoarticular tumors.
The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.
Detailed description
Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.
Histologic analysis will be used as a gold standard.
The following imaging techniques will be evaluated:
- contrast enhanced ultrasonography
- Low dose CT perfusion
- Magnetic resonance perfusion
- Diffusion weighted imaging
- Magnetic resonance proton spectroscopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bone or peripheral soft-tissue tumor | Experimental | Other: Ecography, Other: CT scan, Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
- patients with normal awareness level
- patients having signed informed consent
Key exclusion criteria (10 listed)
- pregnant women
- persons deprived of liberty
- persons under legal protection or unable to give informed consent
- persons in life-threatening emergency
- allergy to Sonovue, iodinated contrast media or gadolinium chelates
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 |
|---|---|---|
| EcographyStandard Doppler ultrasound and perfusion imaging after injection of Sonovue | Other | Patients with bone or peripheral soft-tissue tumor |
| CT scanWith injection of Iomeron 400 | Other | Patients with bone or peripheral soft-tissue tumor |
| MRIWith injection of gadolinium (Multihance) | Other | Patients with bone or peripheral soft-tissue tumor |
Primary outcome
Contrast enhancement in echography: yes or no
Time frame: baseline
Contrast enhancement curve (absent, slow or fast) in echography
Time frame: baseline
Maximal intensity of enhancement peak in echography
Time frame: baseline
Mean transit time of enhancement in echography
Time frame: baseline
Gradient of contrast enhancement curve in echography
Time frame: baseline
Vascularization (dynamic analysis) in CT scanner
Time frame: baseline
* 0: absent * 1: low (< 20UH) * 2: > 20 UH without new blood vessels * 3: > 20 UH and/or with new blood vessels
Contrast enhancement curve (absent, slow or fast) in CT scanner
Time frame: baseline
Maximal intensity of enhancement peak in CT scanner
Time frame: baseline
Mean transit time of enhancement in CT scanner
Time frame: baseline
Gradient of contrast enhancement curve in CT scanner
Time frame: baseline
Contrast enhancement curve (absent, slow or fast) in MRI
Time frame: baseline
Maximal intensity of enhancement peak in MRI
Time frame: baseline
Mean transit time of enhancement in MRI
Time frame: baseline
Gradient of contrast enhancement curve in MRI
Time frame: baseline
Choline peak in magnetic resonance spectroscopy
Time frame: baseline
Choline presence was defined as a clear metabolite peak at 3.2 ppm
Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging
Time frame: baseline
ADC value in mm2/s
Area under the perfusion curve in MRI
Time frame: baseline
Perfusion curve gradient in MRI
Time frame: baseline
Perfusion time-to-peak in MRI
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Derived from this study: PubMed 33765161Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pedro Augusto GONDIM TEIXEIRA contact
Pedro Augusto GONDIM TEIXEIRA principal investigator
Service d'Imagerie Guilloz, CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecography, CT scan and MRI in people with Bone Tumor and Soft Tissue Tumor, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Augusto GONDIM TEIXEIRA (ped_gt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast enhancement in echography: yes or no (time frame: baseline). The study lists 19 primary outcomes in all. 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 NCT02895633, which also lists 1 linked publication.
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 12 Sep 2016.