NCT05695690

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

January 13, 2023

Last Update Submit

April 8, 2023

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (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

    Baseline

Interventions

UltrasonographyDEVICE

Comparing between value of ultrasound vs MRI in uterine fibroids

Also known as: MRI

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All females known or clinically suspected to have uterine fibroids

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33385249BACKGROUND

  • 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.

    PMID: 34581926BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ashraqat Sherif

CONTACT

01062389453ashrakat.gehad@gmail.com

Momtaz Thabet, Lecturer

CONTACT

01062013112mthabetallam@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

May 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

April 11, 2023

Record last verified: 2023-04