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NCT Number: NCT06908655

Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

C01 - Cochin Port Royal, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

    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

  2. Total volume evaluated by MRI-based tractography

    Time frame: Between 7 and 60 days after inclusion

    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.

  3. Length of branches evaluated by MRI-based tractography.

    Time frame: Between 7 and 60 days after inclusion

    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.

  4. Number of branches evaluated by MRI-based tractography.

    Time frame: Between 7 and 60 days after inclusion

    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.

  5. Tortuosity evaluated by MRI-based tractography.

    Time frame: Between 7 and 60 days after inclusion

    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.

  6. Proportion of patients with nerve lesions, in patients with endometriosis

    Time frame: Baseline

    Qualitative assessment of the presence of

    • localised lesions
    • diffuse lesions along the plexus

  7. Inter-reader reproductibilty of nerve lesions, in patients with endometriosis

    Time frame: Baseline

    Cohen's Kappa for reproducibility between 2 readers who performed the qualitative assessment of the presence of

    • localised lesions
    • diffuse lesions along the plexus

  8. Fractional Anisotropy, in patients with vs without endometriosis

    Time frame: Between 7 and 60 days after inclusion

    Comparisons between patients with vs without endometriosis.

    Individual parameters :

    • mean diffusity
    • axial diffusity
    • radial diffusity

  9. Scores at EHP5 Quality of Life questionnaires, in patients with endometriosis

    Time frame: Baseline

    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.

  10. Scores at EHP30 Quality of Life questionnaires, in patients with endometriosis

    Time frame: Baseline

    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.

  11. DN4-based and visual analog scale for pain assessment, in patients with endometriosis

    Time frame: Baseline

    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

  12. 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

    VAS stands for "Visual Analog Scale". The higher the worse between 0 and 10.

    MRI stands for "Magnetic Resonance Imaging".

  13. Total examination duration and MRI-based sequence acquisition duration, in patients with vs without endometriosis

    Time frame: Between 7 and 60 days after inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Cléo Bourgeois

CONTACT

[email protected]

0156095638 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Imagine Institute
  • Sauver la vie Fundation

Registry information

Acronym: TENDANSE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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