ENDOMED: Evaluation of the Evolution of Endometriosis Lesions on Imaging Under Medical Treatment

NCT05722314 | Unknown

• 1 other identifier: ENDOMED FIGUIER
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a difficult disease to diagnose because the symptoms are varied, unspecific and inconsistent from one patient to another. Magnetic resonance imaging is the gold standard for the diagnosis, staging and follow-up of this pathology. Moreover, the management of endometriosis can be medical or surgical depending on the severity and location of the lesions and the patient's expectations. The recommendations of the National College of Obstetricians and Gynecologists and the French National Health Authority are medical treatment first in a certain number of situations. These patients undergoing medical treatment then require close clinical and radiological follow-up in order to evaluate the effectiveness of the treatment and the evolution of the disease. The literature describes the appearance of endometriosis lesions on pelvic MRI quite well for the establishment of the diagnosis, but there are few data on the evolution and imaging description of these lesions when hormonal treatment is in progress. Thus, we decided to evaluate and describe the evolution of endometriosis lesions on magnetic resonance imaging under medical treatment and to examine a correlation between this radiological evolution and the clinical evolution of the patients.

Conditions

Endometriosis Pelvic

Keywords

Endometriosis; hormonal treatment; Endometrioma; MRI; Deep Endometriosis; rectovaginal nodule

Outcome Measures

Primary Outcomes (1)

• Evolution of lesions

  To compare endometriosis lesions on pelvic MRI before and after one year of hormonal treatment. The size, appearance and location of the lesions will be compared

  2 years

Secondary Outcomes (2)

• Clinical evaluation

  2 years

• Clinical evaluation 2

  2 years

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients whose MRI results are in favor of deep endometriosis, taking medical treatment or included in a MAP program or in whom it is agreed to withhold treatment (by patient choice, refusal of initial medical or surgical management, desire for spontaneous pregnancy, etc.).

You may qualify if:

• No history of endometriosis surgery
• Diagnosis of endometriosis suspected by an MRI performed or reviewed in a reference center
• Presence of symptomatology requiring medical treatment

You may not qualify if:

• Pregnant or postmenopausal patient
• Not speaking French, not affiliated to the french social security system
• Minors or under guardianship
• Need for surgical management in the first instance
• Contraindication to MRI (claustrophobia, renal insufficiency, gadolinium allergy, intracorporeal presence of metallic implant)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Claire Figuier

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 10, 2023
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2024
• Last Updated: February 10, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)