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.
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.
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.
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.
- First posted25 Jan 2023
- Study startMay 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraqat Mohamed Sherif, Assiut University
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 33385249Bajaj 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Uterine Fibroids Characterization Compared With MRI Using FIGO Classification System
- ClinicalTrials.gov ID
- NCT05695690
- Acronym / sponsor ID
- MRI and US in uterine fibroids
- Conditions
- Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All females known or clinically suspected to have uterine fibroids
Key inclusion criteria (1 listed)
- All females known or clinically suspected to have uterine fibroids \& fit for the MRI examination.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyAlso: MRIComparing between value of ultrasound vs MRI in uterine fibroids | Device | – |
Primary outcome
Comparison of MRI with Ultrasonography in characterization of uterine fibroids using FIGO classification system
Time frame: Baseline
Evaluation of diagnostic accuracy of ultrasound in uterine fibroid characterization compared with MRI using FIGO classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 33385249Gomez 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.
- Background: PubMed 34581926Bajaj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.