Actively Recruiting

Age: 18Years +
FEMALE
ID04990076

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

1500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how accurately the MUSA terms and definitions can diagnose different types of myometrial lesions larger than 1 cm, such as benign fibroids, adenomyomas, or malignant uterine sarcomas. The study also seeks to develop a prediction model to distinguish between benign and malignant myometrial lesions based on selected ultrasound characteristics. The evaluation is supported by prior data estimating a 4.9% incidence of uterine sarcomas in women with myometrial lesions. Patients scheduled for hysterectomy due to myometrial pathology will undergo a detailed preoperative ultrasound scan assessing about 50 ultrasound features. The study includes various types of hysterectomy procedures, such as vaginal, total abdominal, laparoscopic, or robotic hysterectomy, ensuring the uterus is removed intact. In cases where surgery is not possible, a representative biopsy may be performed if justified by oncology specialists. Participants will be closely monitored through ultrasound assessments before their surgery, with researchers measuring the diagnostic accuracy of MUSA terms. The main outcome is to evaluate how well these ultrasound definitions identify lesion types over a four-year period. Additionally, the development of a predictive model based on specific ultrasound features will be studied over five years. The study tracks patient histology results post-surgery and aims to improve diagnosis and treatment planning for myometrial lesions.

CONDITIONS

Brief Title

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients planned for hysterectomy due to myometrial pathology with lesions larger than 1 cm (e.g., fibroid, focal adenomyosis, uterine sarcoma)
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Age under 18 years
  • Polymyomatous uterus
  • Myometrial lesions smaller than 10 mm
  • Current treatment for another cancer
  • Presence of ovarian, endometrial, or cervical pathology
  • Use of power morcellation during surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week before surgery

Participants undergo a systematic preoperative ultrasound scan to assess ultrasound characteristics of their myometrial lesion.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo hysterectomy surgery to remove the uterus containing the myometrial lesion, or a representative biopsy if surgery is not possible.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants' diagnostic ultrasound results are compared with histological outcomes over time to evaluate diagnostic accuracy and develop prediction models.

Follow-up assessments as per clinical care

Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 300

Actively Recruiting

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Research Team

C

Christine De Bruyn, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group.

T Van den Bosch, M Dueholm, F P G Leone...

https://pubmed.ncbi.nlm.nih.gov/25652685