Ovarian EndometriomaNCT05104086
Ultrasound Elastography in Diffferentiation of Endometriomas and Hemorrhagic Cysts
A study testing ultrasound elastography in people with Ovarian Endometrioma, run by Mansoura University at 1 site in Egypt.
Trial summary
To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- ultrasound elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2020to 25 Dec 2021
- 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 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient suspected to have endometrioma or hemorrhagic ovarian cysts.
Who cannot join
- Simple cysts which were defined as a sonolucent thin-walled (<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections [12].
- Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography
Trial locations and contacts
1 site in 1 country.
alaa mosbah, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate, 35111
hala hafez, resident, 01027292006, halahafez193@gmail.com
alaa mosbah, professor, alaamosbah@hotmail.com
About this study
Official title: Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts
To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts
Read the detailed description
The participants will be subjected to:
- Personal, Obstetric and gynecological History taking.
- Clinical examination.
- B-mode ultrasonography was performed to characterize the adnexal masses morphologically.
- Color Doppler ultrasound.
- Grayscale and elastographic ultrasound examination, which will be done using acoustic radiation force impulse (ARFI) imaging with virtual touch quantification (VTQ). Five consecutive measurements were recorded for each lesion from the region identified as the region of interest (ROI) and the median of these measurements was recorded as the shear wave velocity (SWV) value of the lesion. In virtual touch quantification (VTQ) the shear wave speed is expressed in m/s. Only numerical results will be taken into consideration. . Realtime elastographic and B-mode images simultaneously will appear as a two-panel image. Elastogram appeared in the region of interest (ROI) box to determine the target ovarian lesion and surrounding tissue, then elasticity colour code will be classified in 5 patterns : pattern 1, an absent or a very small hard area; pattern 2, hard area 45 per cent; pattern 4, peripheral hard and central soft areas; pattern 5, hard area occupying entire solid component with or without soft rim. Strain index will be analyzed, which will be obtained by comparing the absolute strain value of solid component of ovarian cyst with that of surrounding soft tissue.
- The invistigator will reevaluate the lesions 4 weeks after the initial assessment to see the possible changes in the size and/or configuration of the lesions with B-mode and elastographic ultrasonography.
- Lesion will be evaluated as endometriomas and referred for surgery when shows no significant changes in size and configuration.
- Hemorrhagic cyst diagnosis will be made if the lesion had resolved on follow-up.
- Conditions
- Ovarian Endometrioma
- Being tested
- ultrasound elastography
- Keywords
- ultrasound elastography
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound elastographyDevice
strain ratio and resistivity index
| Study group | Role | What they receive |
|---|---|---|
| evaluate the value of ultrasound elastography in dignosis of endometriomas | Active comparator | evaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks Receives: Device: ultrasound elastography |
| evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts | Active comparator | revaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values Receives: Device: ultrasound elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts
the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start25 Dec 2020
- Primary completion25 Nov 2021 (estimated)
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa mosbah, professor, Principal investigator, Mansoura university faculty of medicine,obestetric and gynecology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104086
- Sponsor's protocol ID
- MS.19.09.821
- Status last verified
- Sep 2021
- First submitted
- 8 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Elastography in Differentiation of Endometriomas and Hemorrhagic Ovarian Cysts
- ClinicalTrials.gov ID
- NCT05104086
- Acronym / sponsor ID
- MS.19.09.821
- Conditions
- Ovarian Endometrioma
- Keywords
- ultrasound elastography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 25 Nov 2021 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 2 Nov 2021 (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.
To investigate the value of ultrasound elastography in differentiating endometriomas from ovarian hemorrhagic cysts
Detailed description
The participants will be subjected to:
- Personal, Obstetric and gynecological History taking.
- Clinical examination.
- B-mode ultrasonography was performed to characterize the adnexal masses morphologically.
- Color Doppler ultrasound.
- Grayscale and elastographic ultrasound examination, which will be done using acoustic radiation force impulse (ARFI) imaging with virtual touch quantification (VTQ). Five consecutive measurements were recorded for each lesion from the region identified as the region of interest (ROI) and the median of these measurements was recorded as the shear wave velocity (SWV) value of the lesion. In virtual touch quantification (VTQ) the shear wave speed is expressed in m/s. Only numerical results will be taken into consideration. . Realtime elastographic and B-mode images simultaneously will appear as a two-panel image. Elastogram appeared in the region of interest (ROI) box to determine the target ovarian lesion and surrounding tissue, then elasticity colour code will be classified in 5 patterns : pattern 1, an absent or a very small hard area; pattern 2, hard area 45 per cent; pattern 4, peripheral hard and central soft areas; pattern 5, hard area occupying entire solid component with or without soft rim. Strain index will be analyzed, which will be obtained by comparing the absolute strain value of solid component of ovarian cyst with that of surrounding soft tissue.
- The invistigator will reevaluate the lesions 4 weeks after the initial assessment to see the possible changes in the size and/or configuration of the lesions with B-mode and elastographic ultrasonography.
- Lesion will be evaluated as endometriomas and referred for surgery when shows no significant changes in size and configuration.
- Hemorrhagic cyst diagnosis will be made if the lesion had resolved on follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| evaluate the value of ultrasound elastography in dignosis of endometriomas | Active comparator | Device: ultrasound elastographyevaluation of endometrioma by ultrasound elastography and will be repeated after 4 weeks |
| evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts | Active comparator | Device: ultrasound elastographyrevaluation of ovarian hemorrhagic cyst by ultrasound elastography and noticing the change of values |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient suspected to have endometrioma or hemorrhagic ovarian cysts.
Key exclusion criteria (2 listed)
- Simple cysts which were defined as a sonolucent thin-walled (<3 mm thick) cyst larger than 3 cm in diameter without septations or papillary projections [12].
- Hemorrhagic cysts containing septations or mural nodules with detectable flow on Doppler ultrasonography
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 |
|---|---|---|
| ultrasound elastographystrain ratio and resistivity index | Device | evaluate the value of ultrasound elastography in dignosis of endometriomas, evaluate the value of ultrasound elastography in ovarian hemorrhagic cysts |
Primary outcome
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts
Time frame: 4 weeks
the cut of value of strain ratio in diagnosis of endometrioma and ovarian hemorrhagic cyst
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: No
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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.
alaa mosbah, professor contact
Alaa mosbah, professor principal investigator
Mansoura university faculty of medicine,obestetric and gynecology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound elastography in people with Ovarian Endometrioma, run by Mansoura 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 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 2 Nov 2021. 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 hala hafez, resident (00201027292006, halahafez193@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evalute the value of ultrasound elastography in differentiation in endometriomas and ovarian hemorrhagic cysts (time frame: 4 weeks). 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 2 Nov 2021.