EndometriosisTENDANSENCT06908655
Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
A study testing MRI in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Apr 2025to 30 Apr 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years
- Non-menopausal (menopause defined as absence of menstrual periods for 12 consecutive months)
- Referred to the department for clinical suspicion of endometriosis on questioning Or known endometriosis
- Requiring specialized MRI by a specialist in endometriosis and adenomyosis imaging for diagnosis or follow-up of endometriosis.
- Patient affiliated to social security
- Patient with signed informed consent
- Patient with a good understanding of the French language
Who cannot join
- Pregnant or breast-feeding women
- Contraindication to MRI: ocular metallic foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm;
- Claustrophobic patients
- Contraindication to glucagen injection (anti-peristaltic);
- Previous pelvic surgery;
- Patient having participated in a therapeutic clinical trial involving a new molecule within 30 days prior to inclusion;
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- suffering from a severe chronic disease (cancer, HIV, renal failure, ongoing liver or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory disorders) or gastrointestinal disorders deemed incompatible with the conduct of the study by the investigator;
- Vulnerable patients (legal protection, guardianship, curatorship);
- Patients receiving State Medical Aid.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
C01 - Cochin Port Royal
Paris, 75014
Louis Marcellin, 0158413661 ext. +33, louis.marcellin@aphp.fr
Louis Marcellin
C02-HEGP gynecology
Paris, 75015
Anne-Sophie Bats, 0156093586 ext. +33, anne-sophie.bats@aphp.fr
Anne-Sophie Bats
C03- HEGP radiology
Paris, 75015
Laure Fournier, 0156093851, laure.fournier@aphp.fr
Laure Fournier
About this study
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.
Read more
The research process will be as follows:
- Visit 0 (V0): Initial consultation to assess your state of health, complete pain questionnaires (EHP5, EHP30, DN4, EVA), and obtain your informed consent. Prescription of MRI.
- Visit 1 (V1): MRI with diffusion tensor imaging (DTI) within 60 days of V0. The MRI examination will be 10 minutes longer than the usual MRI. An intramuscular injection of glucagon hydrochloride will be given as part of the treatment.
- Visit 2 (V2): Follow-up consultation at 3 months, where the results of the standard MRI sequences will be discussed.
Research constraints and modalities:
- The addition of the DTI sequence extends the routine MRI by 10 minutes.
- You must attend each scheduled appointment. If you are unable to attend, please inform your doctor.
- No additional medications, treatments or samples are required for this study. You will be expected to follow your usual endometriosis treatments, with no specific restrictions on the drugs used, but please report any use of alternative medicine to your doctor.
No additional hospitalization is planned.
- Conditions
- Endometriosis
- Being tested
- MRI
- Keywords
- endometriosis, tractography, pelvic nervous tract
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- total volume
- lengths
- number of branches
- tortuosity MRI will be exploited by independant readers, blinded from patients'clinical characteristics and diagnosis
Measured: Between 7 and 60 days after inclusion
Secondary outcomes (13)
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:
- total volume
- lengths
- number of branches
- tortuosity
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between 7 and 60 days after inclusion
Proportion of patients with nerve lesions, in patients with endometriosis
Qualitative assessment of the presence of
- localised lesions
- diffuse lesions along the plexus
Measured: 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
- localised lesions
- diffuse lesions along the plexus
Measured: Baseline
Fractional Anisotropy, in patients with vs without endometriosis
Comparisons between patients with vs without endometriosis.
Individual parameters :
- mean diffusity
- axial diffusity
- radial diffusity
Measured: 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.
Measured: 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.
Measured: 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 :
- dysmenorrhea
- deep dyspareunia
- non-cyclic chronic pelvic pains
- digestive pains
- urinary pains
Measured: 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".
Measured: Between 7 and 60 days after inclusion
Total examination duration and MRI-based sequence acquisition duration, in patients with vs without endometriosis
Measured: Between 7 and 60 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, non-randomized, multicenter, diagnostic study.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Imagine Institute, Sauver la vie Fundation
- Responsible party
- Sponsor
- Investigators
- Louis Marcellin, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908655
- Sponsor's protocol ID
- APHP241481
- Other IDs
- 2024-A00538-39, 24.05788.000362
- Acronym
- TENDANSE
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
- ClinicalTrials.gov ID
- NCT06908655
- Acronym / sponsor ID
- TENDANSE / APHP241481
- Conditions
- Endometriosis
- Keywords
- endometriosis, tractography, pelvic nervous tract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Imagine Institute, Sauver la vie Fundation
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Apr 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.
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:
- Visit 0 (V0): Initial consultation to assess your state of health, complete pain questionnaires (EHP5, EHP30, DN4, EVA), and obtain your informed consent. Prescription of MRI.
- Visit 1 (V1): MRI with diffusion tensor imaging (DTI) within 60 days of V0. The MRI examination will be 10 minutes longer than the usual MRI. An intramuscular injection of glucagon hydrochloride will be given as part of the treatment.
- Visit 2 (V2): Follow-up consultation at 3 months, where the results of the standard MRI sequences will be discussed.
Research constraints and modalities:
- The addition of the DTI sequence extends the routine MRI by 10 minutes.
- You must attend each scheduled appointment. If you are unable to attend, please inform your doctor.
- No additional medications, treatments or samples are required for this study. You will be expected to follow your usual endometriosis treatments, with no specific restrictions on the drugs used, but please report any use of alternative medicine to your doctor.
No additional hospitalization is planned.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, non-randomized, multicenter, diagnostic study.
| Arm | Type | Receives |
|---|---|---|
| Patients with symptoms compatible with possible endometriosis | Experimental | Other: MRIPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged ≥ 18 years
- Non-menopausal (menopause defined as absence of menstrual periods for 12 consecutive months)
- Referred to the department for clinical suspicion of endometriosis on questioning Or known endometriosis
- Requiring specialized MRI by a specialist in endometriosis and adenomyosis imaging for diagnosis or follow-up of endometriosis.
- Patient affiliated to social security
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women
- Contraindication to MRI: ocular metallic foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm;
- Claustrophobic patients
- Contraindication to glucagen injection (anti-peristaltic);
- Previous pelvic surgery;
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 |
|---|---|---|
| MRIThe 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. | Other | Patients with symptoms compatible with possible endometriosis |
Primary outcome
At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis.
Time frame: 3 months
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.
Proportion of patients with at least one relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis
Time frame: Between 7 and 60 days after inclusion
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: * total volume * lengths * number of branches * tortuosity MRI will be exploited by independant readers, blinded from patients'clinical characteristics and diagnosis
13 secondary outcomes
Proportion of patients with an individual relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis
Time frame: Between 7 and 60 days after inclusion
Total volume evaluated by MRI-based tractography
Time frame: Between 7 and 60 days after inclusion
Length of branches evaluated by MRI-based tractography.
Time frame: Between 7 and 60 days after inclusion
Number of branches evaluated by MRI-based tractography.
Time frame: Between 7 and 60 days after inclusion
Tortuosity evaluated by MRI-based tractography.
Time frame: Between 7 and 60 days after inclusion
Proportion of patients with nerve lesions, in patients with endometriosis
Time frame: Baseline
Inter-reader reproductibilty of nerve lesions, in patients with endometriosis
Time frame: Baseline
Fractional Anisotropy, in patients with vs without endometriosis
Time frame: Between 7 and 60 days after inclusion
Scores at EHP5 Quality of Life questionnaires, in patients with endometriosis
Time frame: Baseline
Scores at EHP30 Quality of Life questionnaires, in patients with endometriosis
Time frame: Baseline
DN4-based and visual analog scale for pain assessment, in patients with endometriosis
Time frame: Baseline
VAS for pain assessement at the end of MRI-based diffusion tensor sequence, in patients with vs without endometriosis
Time frame: Between 7 and 60 days after inclusion
Total examination duration and MRI-based sequence acquisition duration, in patients with vs without endometriosis
Time frame: Between 7 and 60 days after inclusion
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 3 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Louis Marcellin principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Endometriosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 7 inclusion and 9 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Cléo Bourgeois (0156095638 ext. +33, cleo.bourgeois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.