Orbital TumorPERFORMNCT02434120
MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)
An observational study of Orbital Tumor, 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
- How many people
- 238 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to 8 Aug 2022
- 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: Patients undergoing a MRI because of an orbital mass
Who may be able to join
- Patient aged 18 years or more
- with orbital mass for which a biopsy and/or a surgical removal is planned
- undergoing an MRI
- before surgery
Who cannot join
- contra-indication to MRI
- intolerance to constrast agent
- pregnancy
- breast feeding
- patient under a legal protection procedure
- patient denying to participate to the study
- lack of affiliation to a social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
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.
For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.
In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.
- Conditions
- Orbital Tumor
- Keywords
- MRI, Orbital neoplasm
- Medical subject headings
- Orbital Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startNov 2015
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orbital TumorStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 238 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
- NCT02434120
- Sponsor's protocol ID
- ALR_2015_13
- Acronym
- PERFORM
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2015
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Shaughnessy E, Cossec CL, Mambour N, Lecoeuvre A, Savatovsky J, Zmuda M, Duron L, Lecler A. Diagnostic Performance of Dynamic Contrast-Enhanced 3T MR Imaging for Characterization of Orbital Lesions: Validation in a Large Prospective Study. AJNR Am J Neuroradiol. 2024 Mar 7;45(3):342-350. doi: 10.3174/ajnr.A8131.
PubMed 38453407O'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
- Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
- ClinicalTrials.gov ID
- NCT02434120
- Acronym / sponsor ID
- PERFORM / ALR_2015_13
- Conditions
- Orbital Tumor
- Keywords
- MRI, Orbital neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Nov 2015 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 5 May 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.
For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.
In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a MRI because of an orbital mass
Key inclusion criteria (4 listed)
- Patient aged 18 years or more
- with orbital mass for which a biopsy and/or a surgical removal is planned
- undergoing an MRI
- before surgery
Key exclusion criteria (7 listed)
- contra-indication to MRI
- intolerance to constrast agent
- pregnancy
- breast feeding
- patient under a legal protection procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient
Time frame: one 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 38453407O'Shaughnessy E, Cossec CL, Mambour N, Lecoeuvre A, Savatovsky J, Zmuda M, Duron L, Lecler A. Diagnostic Performance of Dynamic Contrast-Enhanced 3T MR Imaging for Characterization of Orbital Lesions: Validation in a Large Prospective Study. AJNR Am J Neuroradiol. 2024 Mar 7;45(3):342-350. doi: 10.3174/ajnr.A8131.
- 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, 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 4 inclusion and 7 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?
Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient (time frame: one 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 NCT02434120, which also lists 2 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 16 Apr 2024.