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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00538-39 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé | |
| 24.05788.000362 | Other Identifier | Commission Nationale des Recherche Impliquant la Personne Humaine |
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| Name | Class |
|---|---|
| Imagine Institute | OTHER |
| Sauver la vie Fundation | UNKNOWN |
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This research focuses on evaluating the ability of diffusion tensor imaging (DTI) to detect nerve damage in pelvic endometriosis. The primary objective is to visualize pelvic nerve plexuses to better understand the mechanisms of endometriosis-related neuropathic pain. Secondary objectives include comparing nerve damage between women with and without endometriosis.
To answer this question, it is planned to include 110 women with symptoms compatible with endometriosis, in Paris hospitals (Hôpital Cochin and HEGP). This research is funded by Assistance Publique - Hôpitaux de Paris. The expected duration of the research is 2 years, with individual participation of 3 months.
The research process will be as follows:
Research constraints and modalities:
No additional hospitalization is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with symptoms compatible with possible endometriosis | Experimental | Patients will have an initial gynecological surgery consultation to determine the indication for MRI to diagnose and/or assess pelvic endometriosis. MRI will be performed at the HEGP, comprising a T2-weighted isotropic thin-section (3D) cube sequence (1 mm3), and a T1-weighted isotropic 3D DIXON sequence (1 mm3), for a total duration of 20 minutes (including set-up). Patients will also have a pelvic ultrasound if they have not already had one at a center specializing in endometriosis. They will have a further consultation after the MRI, so that the gynecological surgeon can discuss therapeutic management. All these procedures are performed as part of routine management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | The procedure to be investigated will be to perform a diffusion tensor sequence during the MRI indicated as part of the treatment. The diffusion tensor sequence takes 10 minutes to acquire, for a total examination time of 30 minutes instead of 20 minutes, including set-up. |
| Measure | Description | Time Frame |
|---|---|---|
| At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis. | Evaluate the ability of the diffusion tensor sequence to visualize normal or pathological pelvic nerve plexuses (hypogastric and sciatic) in pelvic endometriosis. These parameters will be measured on MRI tractography images. | 3 months |
| Proportion of patients with at least one relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis | Number of patients (with or without endometriosis) in whom at least one parameter could be evaluated, divided by the total number of patients (with or without endometriosis) who attended an MRI-based tractography. Parameters expected to be evaluable with MRI-based tractography:
| Between 7 and 60 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an individual relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis | Number of patients (with or without endometriosis) in whom the individual parameter could be evaluated, divided by the total number of patients (with or without endometriosis) who attended an MRI-based tractography. Individual parameters expected to be evaluable with MRI-based tractography:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cléo Bourgeois | Contact | 0156095638 | +33 | cleo.bourgeois@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Louis Marcellin | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C01 - Cochin Port Royal | Paris | 75014 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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This is a prospective, non-randomized, multicenter, diagnostic study.
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|
| Between 7 and 60 days after inclusion |
| Total volume evaluated by MRI-based tractography | MRI stands for "Magnetic Resonance Imaging". In patients with vs without endometriosis: comparisons between patients with vs without endometriosis. In patients with endometriosis: comparisons according to (i) presence of endometriosis lesions (yes vs no), (ii) pain type (neuropathic vs other), (iii) endometriosis phenotype (endometriom vs deep endometriosis), (iv) localisation of lesions (pelvic wall vs sacro-rectus-genitourinary blade vs iliac incisure), all subgroups evaluated at inclusion. | Between 7 and 60 days after inclusion |
| Length of branches evaluated by MRI-based tractography. | MRI stands for "Magnetic Resonance Imaging". In patients with vs without endometriosis: comparisons between patients with vs without endometriosis. In patients with endometriosis: comparisons according to (i) presence of endometriosis lesions (yes vs no), (ii) pain type (neuropathic vs other), (iii) endometriosis phenotype (endometriom vs deep endometriosis), (iv) localisation of lesions (pelvic wall vs sacro-rectus-genitourinary blade vs iliac incisure), all subgroups evaluated at inclusion. | Between 7 and 60 days after inclusion |
| Number of branches evaluated by MRI-based tractography. | MRI stands for "Magnetic Resonance Imaging". In patients with vs without endometriosis: comparisons between patients with vs without endometriosis. In patients with endometriosis: comparisons according to (i) presence of endometriosis lesions (yes vs no), (ii) pain type (neuropathic vs other), (iii) endometriosis phenotype (endometriom vs deep endometriosis), (iv) localisation of lesions (pelvic wall vs sacro-rectus-genitourinary blade vs iliac incisure), all subgroups evaluated at inclusion. | Between 7 and 60 days after inclusion |
| Tortuosity evaluated by MRI-based tractography. | MRI stands for "Magnetic Resonance Imaging". In patients with vs without endometriosis: comparisons between patients with vs without endometriosis. In patients with endometriosis: comparisons according to (i) presence of endometriosis lesions (yes vs no), (ii) pain type (neuropathic vs other), (iii) endometriosis phenotype (endometriom vs deep endometriosis), (iv) localisation of lesions (pelvic wall vs sacro-rectus-genitourinary blade vs iliac incisure), all subgroups evaluated at inclusion. | Between 7 and 60 days after inclusion |
| Proportion of patients with nerve lesions, in patients with endometriosis | Qualitative assessment of the presence of
| Baseline |
| Inter-reader reproductibilty of nerve lesions, in patients with endometriosis | Cohen's Kappa for reproducibility between 2 readers who performed the qualitative assessment of the presence of
| Baseline |
| Fractional Anisotropy, in patients with vs without endometriosis | Comparisons between patients with vs without endometriosis. Individual parameters :
| Between 7 and 60 days after inclusion |
| Scores at EHP5 Quality of Life questionnaires, in patients with endometriosis | EHP-5 stands for "Endometriosis Health Profiles in 5 items". The higher the worse between 0 and 100. Sum of answer at each item divided by the number of answered items. Individual item of the EHP-5. | Baseline |
| Scores at EHP30 Quality of Life questionnaires, in patients with endometriosis | EHP-30 stands for "Endometriosis Health Profiles in 30 core-items". The higher the worse between 0 and 100. Sum of score at each scale divided by the number of answered scales. Individual score at each scale of the EHP-30. | Baseline |
| DN4-based and visual analog scale for pain assessment, in patients with endometriosis | DN4 stands for " Douleur Neuropathique en 4 questions " or " Neuropathic pain in 4 questions ". The higher the worse between 0 and 10. VAS stands for "Visual Analog Scale". The higher the worse between 0 and 10. Score at each part of DN4 pain questionnaire. Score at part 4 on deep pain augmented by 3 items: (i) search for sensation of vice, tightness, heaviness, (ii) search for sensation of digestive or bladder spasm, (iii) pelvic floor muscle tension Individual item of DN4 pain questionnaire. Individual VAS assessing the maximum pain in the 3 months preceding the MRI, on :
| Baseline |
| VAS for pain assessement at the end of MRI-based diffusion tensor sequence, in patients with vs without endometriosis | VAS stands for "Visual Analog Scale". The higher the worse between 0 and 10. MRI stands for "Magnetic Resonance Imaging". | Between 7 and 60 days after inclusion |
| Total examination duration and MRI-based sequence acquisition duration, in patients with vs without endometriosis | Between 7 and 60 days after inclusion |
| C02-HEGP gynecology | Paris | 75015 | France |
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| C03- HEGP radiology | Paris | 75015 | France |
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| D000091662 | Genital Diseases |