Role of MRI in Diagnosis of Postmenopausal Bleeding Causes

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

Postmenopausal bleeding is a common clinical problem accounting for approximately 5% of office visits to a general gynecologist. Postmenopausal bleeding has been defined as: 1. Vaginal bleeding occurring at least 6 months after complete cessation of menses in women not on hormonal replacement therapy (HRT). 2. Noncyclic vaginal bleeding occurring in postmenopausal women who are receiving HRT Abnormal vaginal bleeding may be caused by a number of gynecologic or nongynecologic disorders. When evaluating a gynecologic etiology, the primary goal is to eliminate the possibility of endometrial cancer which is the cause of bleeding in approximately 10% of postmenopausal women presenting with this complaint and is the presenting symptom in 90% of women with endometrial cancer. Other common gynecologic etiologies include endometrial polyps, endometrial hyperplasia, and submucosal fibroids along with the use of hormone replacement therapy, tamoxifen, and phytoestrogens Those pathologies should be discriminated to navigate the treatment process. Transvaginal ultrasonography (TVS) is the most efficient first-step technique for diagnosis of postmenopausal bleeding . The sensitivity of TVS to detect endometrial pathologies is high, but its specificity is low . Therefore, biopsy is recommended as a second-step diagnostic method when endometrial thickness exceeds 4 mm . However, endometrial biopsy or dilatation and curettage (D&C) may not be possible in postmenopausal patients due to endometrial atrophy, endometrial adhesions, or the requirement of general anesthesia. . Furthermore, besides pain and discomfort with endometrial sampling procedures, in some occasions such as vaginal/cervical stenosis or pelvic organ prolapse these procedures may be difficult to be done . Additionally, blind sampling may not be an effective approach for diagnosis of focal endometrial lesions and may be subject to sampling error . MRI is an emerging modality for various reasons, such as exquisite soft-tissue resolution, its capability of multiplanar imaging, characterization, high sensitivity, and lack of ionizing radiation. The sensitivity of MRI in identifying acute uterine pathologies is 96.6 % With recent advances in MR imaging techniques, diffusion weighted (DW) imaging and ADC value are useful in characterization of endometrial lesions because malignant lesions show high cellularity with little extracellular space which give restricted motion of water molecules and lower ADC values in contrast to benign lesions and normal tissues . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06004908
Study type	Observational
Source	Assiut University
Contact	kholoud khaled salem, graduated
Phone	01050111754
Email	Kkholod676@gmail.com
Status	Not yet recruiting
Phase
Start date	October 1, 2023
Completion date	November 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05378152` - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity	N/A
Recruiting	`NCT04500496` - Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy	N/A
Completed	`NCT00339651` - Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer
Completed	`NCT01076621` - Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months	N/A
Completed	`NCT03330015` - Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding	N/A
Completed	`NCT03558321` - Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding	N/A
Completed	`NCT02488798` - Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding	N/A
Recruiting	`NCT03543592` - Three-dimensional Power Doppler in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding	N/A
Active, not recruiting	`NCT06293066` - Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study.
Recruiting	`NCT02822885` - Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding	N/A
Completed	`NCT03404154` - Vocal in Assessment of Endometrium in Postmenopause
Not yet recruiting	`NCT03847415` - Endometrial Evaluation in Cases of Postmenopausal Bleeding
Recruiting	`NCT03382145` - A Review on the Outcome of Patient Managed in Postmenopausal Bleeding Clinic
Recruiting	`NCT03841916` - Relation Between Body Mass Index and Endometrial Thickness

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.