Orbital TumorMEDORTNCT02401906
MRI and Orbital Tumours (MEDORT)
An observational study of Orbital Tumor and Orbital Pseudotumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Tumor, Orbital Pseudotumor
- What is being tested?
- MRI
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to 25 May 2020
- Phase
- Observational
- 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
Study population: Patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment
Who may be able to join
- Patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment
Who cannot join
- Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
- Patient under guardianship
- Patient not willing to participate.
- Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
- Motion artifact on the sequences, not corrected by the repeat sequences
- Metal artifact prohibiting the analysis of the region of interest
- Biopsy or resection not performed, particularly if the orbital mass is due to an infection
- MRI findings allowing a diagnosis without the need for pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI for the Etiological Diagnosis of Orbital Tumours
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.
Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.
Read more
The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.
The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).
In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.
The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.
- Conditions
- Orbital Tumor, Orbital Pseudotumor
- Being tested
- MRI
- Medical subject headings
- Orbital Neoplasms, Orbital Pseudotumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity based on the patterns of the intra voxel incoherent motion, the dynamic susceptibility contrast and enhancement, for distinguishing orbital tumors from orbital pseudotumor, the gold standard being the pathological exam.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start27 May 2015
- Primary completion25 May 2020
- Study completion25 May 2020
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 Orbital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401906
- Sponsor's protocol ID
- ALR_2015-8
- Acronym
- MEDORT
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2015
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Shaughnessy E, Senicourt L, Mambour N, Savatovsky J, Duron L, Lecler A. Toward Precision Diagnosis: Machine Learning in Identifying Malignant Orbital Tumors With Multiparametric 3 T MRI. Invest Radiol. 2024 Oct 1;59(10):737-745. doi: 10.1097/RLI.0000000000001076. Epub 2024 Apr 11.
PubMed 38597586
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for the Etiological Diagnosis of Orbital Tumours
- ClinicalTrials.gov ID
- NCT02401906
- Acronym / sponsor ID
- MEDORT / ALR_2015-8
- Conditions
- Orbital Tumor, Orbital Pseudotumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 27 May 2015 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 30 Mar 2015 (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.
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.
Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.
The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.
The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).
In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.
The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment
Key inclusion criteria (1 listed)
- Patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an MRI, before any surgical treatment
Key exclusion criteria (8 listed)
- Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
- Patient under guardianship
- Patient not willing to participate.
- Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
- Motion artifact on the sequences, not corrected by the repeat sequences
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 |
|---|---|---|
| MRI | Other | – |
Primary outcome
Sensitivity and specificity based on the patterns of the intra voxel incoherent motion, the dynamic susceptibility contrast and enhancement, for distinguishing orbital tumors from orbital pseudotumor, the gold standard being the pathological exam.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 38597586O'Shaughnessy E, Senicourt L, Mambour N, Savatovsky J, Duron L, Lecler A. Toward Precision Diagnosis: Machine Learning in Identifying Malignant Orbital Tumors With Multiparametric 3 T MRI. Invest Radiol. 2024 Oct 1;59(10):737-745. doi: 10.1097/RLI.0000000000001076. Epub 2024 Apr 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Tumor and Orbital Pseudotumor, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 16 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity based on the patterns of the intra voxel incoherent motion, the dynamic susceptibility contrast and enhancement, for distinguishing orbital tumors from orbital pseudotumor, the gold standard being the pathological exam. (time frame: 1 month). 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 NCT02401906, 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 16 Apr 2024.