Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04554602

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

About this study

The research is about diagnosis performance between fusion ultrasound and the gold standard (MRI coelioscopy ). Fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. During 39 months, 200 patients will be follow. In one arm, there is the control group with women without endometriosis. In the second arm, there is the patient with endometriosis. We will compare monitoring differences between gold standard and fusion ultrasound ( Cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients from 18 to 50 years old
  • Patient informed and who gave her non-opposition to participate in the research
  • Patient with an indication for pelvic MRI and pelvic ultrasound either for the exploration of endometriosis or pelvic pain, or for another gynaecological pathology (ovarian cyst, poly-myomatous uterus, uterine malformation) outside of a proven cancer indication.
  • Patient affiliated to a social security or entitled to a social security allowance

Exclusion criteria

  • Patient with a proven cancerous pathology at the time of the prescription of the complementary examinations.
  • Virgin patient
  • Pregnant patient
  • Patients under protective measures
  • Contraindication to MRI (claustrophobia, intracorporeal metallic foreign body)

Treatment and study plan

Fusion ultrasound

Diagnostic Test

Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.

Primary outcomes

  1. Sensitivity, specificity, positive predictive value (VPP) and negative predictive value (VPN) of fusion ultrasound compared to transvaginal ultrasound and MRI for the diagnosis of endometriosis lesions

    Time frame: 3 years and 3 months

    To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.

Secondary outcomes

  1. Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.

    Time frame: 3 years and 3 months

    Evaluation of the reproducibility by an intra-class correlation test for the conclusions of fusion ultrasound between two operators.

  2. To evaluate the contribution of fusion ultrasound in the follow-up of patients suffering from endometriosis, in particular with an ultrasound follow-up in comparison with an initial reference MRI in the case of medical or surgical management.

    Time frame: 3 years and 3 months

    Correlation between the evolution of clinical and quality of life symptoms (EHP30 form and Short Form 36) and the evolution of lesion size between initial MRI and follow-up ultrasounds at 6 months and one year

  3. Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion

    Time frame: 3 years and 3 months

    Comparison of the average examination time by a Student T-test between standard and fusion ultrasound.

  4. Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance

    Time frame: 3 years and 3 months

    Comparison of imaging costs will be carried out over 3 years between a conventional procedure with annual MRI and the procedure being evaluated

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION

Acronym: ENDOFUSION

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2020
Registry last updated
Jan 25, 2024

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.

Published trials that share one or more normalized conditions with this study.