NCT06004908

Brief Summary

The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding

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
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

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

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 15, 2023

Last Update Submit

August 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

    anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

    baseline

Interventions

MRIDEVICE

a type of scan that uses strong magnetic field sand radio waves to produce detailed images of the inside of the body

Also known as: Magnetic resonance imaging

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any female patient after menopause suffering from vaginal bleeding

You may qualify if:

  • Any female patient after menopause suffering from vaginal bleeding.
  • Patients receiving tamoxifen with vaginal bleeding.
  • Patient had histopathological biopsy examination either by total hysterectomy, hysteroscopy or D \&C.
  • Patient must have local cause

You may not qualify if:

  • \. Patients not amenable for MRI examination 2. Patients not in menopause 3. Patients have general bleeding tendency 4. Patients not underwent histopathological biopsy examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Dubinsky TJ, Parvey HR, Maklad N. The role of transvaginal sonography and endometrial biopsy in the evaluation of peri- and postmenopausal bleeding. AJR Am J Roentgenol. 1997 Jul;169(1):145-9. doi: 10.2214/ajr.169.1.9207515.

    PMID: 9207515BACKGROUND
  • Karlsson B, Granberg S, Wikland M, Ylostalo P, Torvid K, Marsal K, Valentin L. Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding--a Nordic multicenter study. Am J Obstet Gynecol. 1995 May;172(5):1488-94. doi: 10.1016/0002-9378(95)90483-2.

    PMID: 7755059BACKGROUND
  • Gull B, Karlsson B, Milsom I, Granberg S. Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal bleeding and transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol. 2003 Feb;188(2):401-8. doi: 10.1067/mob.2003.154.

    PMID: 12592247BACKGROUND
  • Foti PV, Tonolini M, Costanzo V, Mammino L, Palmucci S, Cianci A, Ettorre GC, Basile A. Cross-sectional imaging of acute gynaecologic disorders: CT and MRI findings with differential diagnosis-part II: uterine emergencies and pelvic inflammatory disease. Insights Imaging. 2019 Dec 20;10(1):118. doi: 10.1186/s13244-019-0807-6.

    PMID: 31858287BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hossam ElDen Mustafa Kamel, MD

    unaffilitated

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kholoud khaled salem, graduated

CONTACT

Mostafa Hashem Mahmoud othma, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 22, 2023

Record last verified: 2023-08