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Uterine FibroidNCT05695690

Role of US in Uterine Fibroids in Comparison With MRI Using FIGO Classification

An observational study of Uterine Fibroid, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Uterine Fibroid
What is being tested?
Ultrasonography
Type of treatment
Medical device
How many people
43 participants
Where
No sites listed yet
Study dates
May 2023to May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Child, Adult, Older adult

Study population: All females known or clinically suspected to have uterine fibroids

Who may be able to join

  • All females known or clinically suspected to have uterine fibroids \& fit for the MRI examination.

Who cannot join

  • Patients with metallic prosthesis which are not MRI compatible.
  • Patients refused the examination.
  • Patients who suffer from claustrophobia.
  • Pregnant women especially in the first trim

Trial locations and contacts

No sites are listed yet.

Momtaz Thabet, Lecturer contact

01062013112

mthabetallam@yahoo.com

About this study

Official title: Role of Ultrasound in Uterine Fibroids Characterization Compared With MRI Using FIGO Classification System

Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification

Read the detailed description

Uterine fibroids, also known as uterine leiomyomata or myomas, are the most common gynecologic tumors occurring in 20-30% of women of reproductive age and in up to 80% of all women.

Leiomyomas have a wide spectrum of clinical presentations, but are mostly asymptomatic. Submucosal leiomyomas are more commonly associated with symptoms such as AUB, dysmenorrhea, infertility, and recurrent pregnancy loss. Subserosal leiomyomas can cause gastrointestinal or genitourinary symptoms related to size such as constipation, urinary retention, urinary frequency and urgency, or bladder and bowel incontinence.

Fibroids are monoclonal smooth muscle tumors arising from the myometrium. While benign, their growth is dependent on estrogen and progesterone levels, and thus fibroids may enlarge with pregnancy and use of oral contraceptives and regress during menopause.

Ultrasonography (USG) is the first-line imaging modality for any suspected structural anomaly of the female pelvis as well as the most appropriate imaging modality for abnormal uterine bleeding. USG has high sensitivity and specificity in diagnosing leiomyomas, but can vary with the experience of the operator performing the USG, ranging from 65 to 99%.

Pelvic USG usually consists of a combined approach to include both transabdominal (TAS) and transvaginal (TVUS) imaging. TVUS is generally considered to be more sensitive and specific with greater contrast and spatial resolution when compared to TAS. TVUS is more useful in obese patients, patients with a large amount of bowel gas, and in patients with incomplete bladder filling, all of which lower the sensitivity of TAS. TAS, on the other hand, is helpful in females with a larger uterus that extends superiorly from the pelvis and cannot be completely visualized in the field of TVUS. TAS provides an anatomic overview to better estimate overall uterine size and visualize the fundus in such cases.

For incomplete visualization or indeterminate US findings, MRI is recommended. MR imaging is considered to be superior to USG offering anatomic detail with increased sensitivity and specificity in mapping the location and size of leiomyomas prior to treatment. Previous studies have shown that MRI has the greatest advantage in diagnosing leiomyomas especially in cases of multiple leiomyomas (> 4) or a large volume uterus (> 375 mL). Through the use of diffusion weighted imaging MR may also help identify lesions with higher cellularity such as leiomyosarcomas.

Despite these limitations, TVUS remains as efficient as MR in detecting the presence of leiomyomas and due to the lower cost, greater availability, and fewer contraindications, USG remains the first-line imaging modality for diagnosing the presence of leiomyomas. Furthermore, Baird et al. found that the presence of leiomyomas on a baseline ultrasound is strongly predictive of future uterine procedures approaching nearly 50% for those patients with a leiomyoma 4 cm or greater at baseline.

Leiomyomas have traditionally been classified as submucosal, intramural, and subserosal. With the advancements in the treatment modalities, there was a need for a more detailed and universally accepted classification system to direct optimal treatment options. For this reason, the FIGO classification system was developed in 2011 for causes of AUB.

The International Federation of Gynecology and Obstetrics (FIGO) classification system for abnormal uterine bleeding is intended to help both clinicians and researchers better categorize the causes of bleeding and plan treatments for the patient, be it hysteroscopy, laparoscopy/laparotomy, or UAE. Precise classification is also necessary in the post-treatment setting in order to assess treatment response, change in overall tumor burden and presence of recurrent lesions. The FIGO classification system subdivides fibroids into submucosal, other (intramural and subserosal), and hybrid types.

Conditions
Uterine Fibroid
Being tested
Ultrasonography
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasonographyDevice

    Also called MRI

    Comparing between value of ultrasound vs MRI in uterine fibroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of MRI with Ultrasonography in characterization of uterine fibroids using FIGO classification system

    Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695690
Sponsor's protocol ID
MRI and US in uterine fibroids
Status last verified
Apr 2023
First submitted
13 Jan 2023
Last updated
11 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gomez E, Nguyen MT, Fursevich D, Macura K, Gupta A. MRI-based pictorial review of the FIGO classification system for uterine fibroids. Abdom Radiol (NY). 2021 May;46(5):2146-2155. doi: 10.1007/s00261-020-02882-z. Epub 2021 Jan 1.

    PubMed 33385249
  • Bajaj S, Gopal N, Clingan MJ, Bhatt S. A pictorial review of ultrasonography of the FIGO classification for uterine leiomyomas. Abdom Radiol (NY). 2022 Jan;47(1):341-351. doi: 10.1007/s00261-021-03283-6. Epub 2021 Sep 28.

    PubMed 34581926

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Fibroid, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ashraqat Sherif (01062389453, ashrakat.gehad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of MRI with Ultrasonography in characterization of uterine fibroids using FIGO classification system (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695690, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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