Postmenopausal BleedingNCT03543592
Three-dimensional Power Doppler in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding
A study testing 3 dimensional ultrasonography and Doppler in people with Postmenopausal Bleeding, run by Cairo University at 1 site in Egypt.
Trial summary
100 women suffering post-menopausal bleeding will be included in the study. All the participants will undergo 3D Transvaginal Ultrasound to assess the endometrium and myometrium (for the presence of any focal lesions e.g. Read more about this study
- Who is it for?
- Ages 50 to 50 years, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- 3 dimensional ultrasonography and Doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 15 Aug 2020
- Phase
- Interventional
- 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 50 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-menopausal bleeding (occurred after at least 12 months of amenorrhea)
Who cannot join
- History of hormone administration in the last 6 months.
- Systemic diseases causing abnormal uterine bleeding as hematologic diseases and chronic medical diseases.
- Women who experienced artificial or induced menopause because of the use of tamoxifen or any type of hormone replacement therapy.
- Patients who take any anticoagulant drugs.
Trial locations and contacts
1 site in 1 country.
Sally El-Attar, MSc contact
Egypt1 site, 1 recruiting
- Recruiting
kasr elaini hospital (Cairo university)
Cairo, 115431
MOUTAZ ELSHERBINI, MD, (+2)01001588300, mizosherbini@yahoo.com
MOUTAZ ELSHERBINI, md
About this study
Official title: The Accuracy of Three-dimensional Power Doppler Ultrasound in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding Compared With the Endometrial Histopathology.
100 women suffering post-menopausal bleeding will be included in the study. All the participants will undergo 3D Transvaginal Ultrasound to assess the endometrium and myometrium (for the presence of any focal lesions e.g. polypi) followed by 3D Power Doppler ultrasound assessment of the vascular indices: vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) and endometrial volumes.
The results of the ultrasound and Doppler indices will be correlated to the histopathological examination of specimens collected following fractional curettage or hysterectomy.
Read the detailed description
100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study.
After obtaining an informed consent entailing the explanation of the study and its aim, all participants will undergo the following; full history taking (including full menstrual history and the date of menopause), complete physical examination, laboratory investigations (complete blood count, liver function tests, kidney function tests and a coagulation profile). Baseline 2D transvaginal ultrasound will be done to measure endometrial thickness and to detect presence of any endometrial and myometrial focal lesions. 3D-transvaginal ultrasonography will be done to acquire multi-planner view of the uterine cavity and detect presence or absence of any cavitary or myometrial lesions and acquire endometrial volumes. This will be followed by 3D Power Doppler Ultrasound assessment of the vascular indices namely; vascularization index (VI), flow index (FI) and vascularization-flow index (VFI).
Transvaginal sonography will be performed for all patients using Voluson 730 PRO V transvaginal volumetric probe transducer with frequency range of 5-8 MHz equipped with color, power and pulsed Doppler capabilities. First, conventional gray-scale sonography will be performed to obtain longitudinal and transverse sections of the uterus. Maximum endometrial thickness (double-layer) will be measured in the longitudinal plane with the detection of any focal lesions.
For Three-Dimensional Ultrasound: Once the B - mode had been completed, three-dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. The probe will be kept steady, the patient will be asked to hold breath and volume mode will be switched on. With the use of the medium line density, the typical acquisition time will be between 4 and 10 seconds. Visualization of the endometrium in the three planes will be done to detect endometrial cavity. Endometrial margin, echogenicity and presence of intrauterine fluid will be examined to notice the presence of any heterogenic pattern, irregularity, asymmetry in the margin or local thickening denoting the presence of polyp, endometrial hyperplasia, or carcinoma. The myometrium will be also examined in the three planes to detect any other focal lesion e.g. Fibroid or Adenomyosis.
For Power Doppler Study, the power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). Power Doppler settings will be set to achieve maximum sensitivity for detecting low velocity flow without noise. Once the vessels have been identified, the pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs. Only endometrial and endometrial-myometrial interface vessels were included.
The patient will then be admitted for either a D and C operation (Endometrial curettage) or for Total Abdominal Hysterectomy. All removed tissues will be sent for histopathological examination of the endometrium or of any pathological uterine lesion. Pathological examination results will be correlated to ultrasound (2D and 3D) and Doppler findings,
- Conditions
- Postmenopausal Bleeding
- Being tested
- 3 dimensional ultrasonography and Doppler
- Keywords
- postmenopausal bleeding, ultrasound, power doppler, endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dimensional ultrasonography and DopplerDiagnostic test
Three-Dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. Visualization of the endometrium and myometrium in the three planes will be done to detect endometrial cavity and any lesions. The power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). The pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs.
| Study group | Role | What they receive |
|---|---|---|
| 3 dimensional power Doppler | Other | 100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study and 3 dimensional ultrasonography and Doppler will be done for them Receives: Diagnostic Test: 3 dimensional ultrasonography and Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic performance of Vascularization index in detecting endometrial carcinoma
Vascularization index (VI) will be correlated to pathology report
Measured: within 24 hours before the surgical procedure
Secondary outcomes (3)
the diagnostic performance of the endometrial volumes acquired by Three-Dimensional Ultrasound
endometrial volumes will be correlated to pathology report
Measured: within 24 hours before the surgical procedure
the diagnostic performance of flow index (FI) in detecting endometrial carcinoma.
flow index will be correlated to pathology report
Measured: within 24 hours before the surgical procedure
the diagnostic performance of vascularization-flow index (VFI) in detecting endometrial carcinoma.
vascularization-flow index (VFI) will be correlated to pathology report
Measured: within 24 hours before the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jun 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moutaz Sherbini, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543592
- Sponsor's protocol ID
- 3081987
- Status last verified
- Jan 2020
- First submitted
- 8 May 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Three-dimensional Power Doppler Ultrasound in the Diagnosis of Endometrial Lesions in Patients With Postmenopausal Bleeding Compared With the Endometrial Histopathology.
- ClinicalTrials.gov ID
- NCT03543592
- Acronym / sponsor ID
- 3081987
- Conditions
- Postmenopausal Bleeding
- Keywords
- postmenopausal bleeding, ultrasound, power doppler, endometrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 1 Jun 2018 (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.
100 women suffering post-menopausal bleeding will be included in the study. All the participants will undergo 3D Transvaginal Ultrasound to assess the endometrium and myometrium (for the presence of any focal lesions e.g. polypi) followed by 3D Power Doppler ultrasound assessment of the vascular indices: vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) and endometrial volumes.
The results of the ultrasound and Doppler indices will be correlated to the histopathological examination of specimens collected following fractional curettage or hysterectomy.
Detailed description
100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study.
After obtaining an informed consent entailing the explanation of the study and its aim, all participants will undergo the following; full history taking (including full menstrual history and the date of menopause), complete physical examination, laboratory investigations (complete blood count, liver function tests, kidney function tests and a coagulation profile). Baseline 2D transvaginal ultrasound will be done to measure endometrial thickness and to detect presence of any endometrial and myometrial focal lesions. 3D-transvaginal ultrasonography will be done to acquire multi-planner view of the uterine cavity and detect presence or absence of any cavitary or myometrial lesions and acquire endometrial volumes. This will be followed by 3D Power Doppler Ultrasound assessment of the vascular indices namely; vascularization index (VI), flow index (FI) and vascularization-flow index (VFI).
Transvaginal sonography will be performed for all patients using Voluson 730 PRO V transvaginal volumetric probe transducer with frequency range of 5-8 MHz equipped with color, power and pulsed Doppler capabilities. First, conventional gray-scale sonography will be performed to obtain longitudinal and transverse sections of the uterus. Maximum endometrial thickness (double-layer) will be measured in the longitudinal plane with the detection of any focal lesions.
For Three-Dimensional Ultrasound: Once the B - mode had been completed, three-dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. The probe will be kept steady, the patient will be asked to hold breath and volume mode will be switched on. With the use of the medium line density, the typical acquisition time will be between 4 and 10 seconds. Visualization of the endometrium in the three planes will be done to detect endometrial cavity. Endometrial margin, echogenicity and presence of intrauterine fluid will be examined to notice the presence of any heterogenic pattern, irregularity, asymmetry in the margin or local thickening denoting the presence of polyp, endometrial hyperplasia, or carcinoma. The myometrium will be also examined in the three planes to detect any other focal lesion e.g. Fibroid or Adenomyosis.
For Power Doppler Study, the power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). Power Doppler settings will be set to achieve maximum sensitivity for detecting low velocity flow without noise. Once the vessels have been identified, the pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs. Only endometrial and endometrial-myometrial interface vessels were included.
The patient will then be admitted for either a D and C operation (Endometrial curettage) or for Total Abdominal Hysterectomy. All removed tissues will be sent for histopathological examination of the endometrium or of any pathological uterine lesion. Pathological examination results will be correlated to ultrasound (2D and 3D) and Doppler findings,
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 dimensional power Doppler | Other | Diagnostic Test: 3 dimensional ultrasonography and Doppler100 women suffering post-menopausal bleeding (occurred after at least 12 months of amenorrhea) will be included in the study and 3 dimensional ultrasonography and Doppler will be done for them |
Who may qualify
- Ages
- 50 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post-menopausal bleeding (occurred after at least 12 months of amenorrhea)
Key exclusion criteria (4 listed)
- History of hormone administration in the last 6 months.
- Systemic diseases causing abnormal uterine bleeding as hematologic diseases and chronic medical diseases.
- Women who experienced artificial or induced menopause because of the use of tamoxifen or any type of hormone replacement therapy.
- Patients who take any anticoagulant drugs.
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 |
|---|---|---|
| 3 dimensional ultrasonography and DopplerThree-Dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. Visualization of the endometrium and myometrium in the three planes will be done to detect endometrial cavity and any lesions. The power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). The pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs. | Diagnostic test | 3 dimensional power Doppler |
Primary outcome
the diagnostic performance of Vascularization index in detecting endometrial carcinoma
Time frame: within 24 hours before the surgical procedure
Vascularization index (VI) will be correlated to pathology report
3 secondary outcomes
the diagnostic performance of the endometrial volumes acquired by Three-Dimensional Ultrasound
Time frame: within 24 hours before the surgical procedure
the diagnostic performance of flow index (FI) in detecting endometrial carcinoma.
Time frame: within 24 hours before the surgical procedure
the diagnostic performance of vascularization-flow index (VFI) in detecting endometrial carcinoma.
Time frame: within 24 hours before the surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Sally El-Attar, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dimensional ultrasonography and Doppler in people with Postmenopausal Bleeding, run by Cairo University at 1 site in Egypt.
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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 moutaz elsherbini, MD (+2 01001588300, mizosherbini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic performance of Vascularization index in detecting endometrial carcinoma (time frame: within 24 hours before the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2020.