Postmenopausal BleedingNCT06004908
Role of MRI in Diagnosis of Postmenopausal Bleeding Causes
An observational study of Postmenopausal Bleeding, run by Assiut University.
Trial summary
The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any female patient after menopause suffering from vaginal bleeding
Who may be able to join
- 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
- -
Who cannot join
- 1. Patients not amenable for MRI examination 2. Patients not in menopause 3. Patients have general bleeding tendency 4. Patients not underwent histopathological biopsy examination
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of MRI in Diagnosis of Causes of Postmenopausal Bleeding in Correlation to Histopathological Results
The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding
Read the detailed 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:
- Vaginal bleeding occurring at least 6 months after complete cessation of menses in women not on hormonal replacement therapy (HRT).
- 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 .
- Conditions
- Postmenopausal Bleeding
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Magnetic resonance imaging
a type of scan that uses strong magnetic field sand radio waves to produce detailed images of the inside of the body
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal BleedingStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Khaled Salem Ali, Assiut University
- Investigators
- Hossam ElDen Mustafa Kamel, MD, Principal investigator, unaffilitated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004908
- Sponsor's protocol ID
- MR imaging in uterus
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9207515Karlsson 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.
PubMed 7755059Gull 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.
PubMed 12592247Foti 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.
PubMed 31858287
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI in Diagnosis of Causes of Postmenopausal Bleeding in Correlation to Histopathological Results
- ClinicalTrials.gov ID
- NCT06004908
- Acronym / sponsor ID
- MR imaging in uterus
- Conditions
- Postmenopausal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 Aug 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.
The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding
Detailed 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:
- Vaginal bleeding occurring at least 6 months after complete cessation of menses in women not on hormonal replacement therapy (HRT).
- 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
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any female patient after menopause suffering from vaginal bleeding
Key inclusion criteria (5 listed)
- 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
- -
Key exclusion criteria (2 listed)
- 1. Patients not amenable for MRI examination 2. Patients not in menopause 3. Patients have general bleeding tendency 4. Patients not underwent histopathological biopsy examination
- -
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 |
|---|---|---|
| MRIAlso: Magnetic resonance imaginga type of scan that uses strong magnetic field sand radio waves to produce detailed images of the inside of the body | Device | – |
Primary outcome
comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding
Time frame: baseline
anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 9207515Dubinsky 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.
- Background: PubMed 7755059Karlsson 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.
- Background: PubMed 12592247Gull 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.
- Background: PubMed 31858287Foti 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.
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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.
Hossam ElDen Mustafa Kamel, MD principal investigator
unaffilitated
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Bleeding, 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 5 inclusion and 2 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 22 Aug 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 kholoud khaled salem, graduated (01050111754, Kkholod676@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding (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 NCT06004908, which also lists 4 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 22 Aug 2023.