Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease

Last updated: February 20, 2025
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma (Pediatric)

Uterina Myoma

Uterine Fibroids

Treatment

ultrasound-guided transuterine vaginal biopsy (BVTE)

Clinical Study ID

NCT06845982
RCAPHM23_0387
2024-A01337-40
  • Ages > 18
  • Female

Study Summary

The benign uterine fibroid is part of the broader term uterine smooth muscle tumour, which also includes malignant myometrial tumours (MSTs) of varying malignancy (uterine sarcoma, cellular fibroid, STUMP (uterine smooth muscle tumours of uncertain malignant potential)).

Magnetic resonance imaging (MRI) is the most effective test for distinguishing a fibroid from a TMM, but its reliability is limited. This leads to inappropriate management in a number of situations. The first is the risk of overtreatment by performing surgery for a suspected TMM on MRI in a patient with few or no symptoms and a final histological diagnosis of fibroid. The second is the risk of unsatisfactory or even harmful cancer surgical treatment in a symptomatic patient with a reassuring MRI diagnosis but a final histological diagnosis of TMM. Finally, there is the possibility of treating a lesion labelled as a fibroid on MRI with an alternative technique (embolisation, radiofrequency, HIFU) when it is in fact a TMM, thereby delaying appropriate treatment and worsening the prognosis.

Ultrasound-guided transuterine vaginal biopsy (ETVB) is an innovative and promising minimally invasive technique for preoperative anatomopathological diagnosis. It would make it possible to obtain a histological diagnosis without the need for surgery, thereby avoiding the inappropriate management described above.

The aim of this study is to validate an innovative minimally invasive surgical technique (BVTE) for the diagnosis of uterine smooth muscle tumours by biopsy, to assess the complications associated with the technique and any potential adverse effects, and to evaluate the feasibility of the technique in current practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age consulting the CHU de la Conception who requiresurgical treatment for uterine smooth muscle tumours (fibroma or TMM).

  • Able to give written consent

  • Beneficiary or beneficiary of a social security scheme

Exclusion

Exclusion Criteria:

  • Person in a period of exclusion from another research protocol at the time ofsigning consent/no objection

  • Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :

  • Pregnant women, women in labour and nursing mothers

  • Persons deprived of their liberty by judicial or administrative decision

  • Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who arenot covered by the provisions of article L1121-8

  • Minors

  • Adults subject to a legal protection measure or unable to express their consent.

  • A person who does not have a sufficient command of reading and understanding theFrench language to be able to consent to participate in the research.

  • Any other reason which, in the opinion of the investigator, could compromise thesafety of the research participant and/or interfere with the evaluation of theobjectives of the research.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: ultrasound-guided transuterine vaginal biopsy (BVTE)
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
October 01, 2028

Connect with a study center

  • Hopital Conception

    Marseille, 13005
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.