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The Use of Doppler to Diagnose Myometrial Masses

Uterine Artery Doppler and Three Dimensional Power Doppler in the Diagnosis of Myometrial Masses

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01833871
Acronym
3D
Enrollment
120
Registered
2013-04-17
Start date
2013-02-28
Completion date
2013-12-31
Last updated
2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Masses

Brief summary

Colour Doppler sonography has also been evaluated in differentiating adenomyosis from fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had vessel distributions different from those found in leiomyoma cases, in addition to a high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding vessels.

Detailed description

Because it is more sensitive, less angle-dependent, and not susceptible to aliasing , power Doppler Sonography has the potential to detect fluctuations in blood flow , with results superior to those of frequency-based color Doppler sonography, particularly in situations of low-velocity blood flow. Three dimensional power Doppler ultrasonography can be applied to differentiate between uterine adenomyosis and leiomyoma ,and it may reduce the number of false positives by detailed investigations.

Interventions

OTHERThree dimensional Power Doppler to the myometrial mass

Trans-vaginal 3D power Doppler Ultrasonographic examination will be done for all participants prior to surgery. The ultrasonographic examination will provide data related to lesion size, lesion volume, vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.

uterine artery Doppler indices(RI,PI) are measured for all cases with myometrial mass

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age between 20 & 60 years. * Asymptomatic pts which discover the mass accidentally . * Patients with symptoms like menorrhagia, menometrorrhagia, dysmenorrheal , abdominal masses. * Patients scheduled for hysterectomy(abdominal/vaginal or Laparoscopic) * Patients scheduled for myomectomy.

Exclusion criteria

* Pregnant patients * Age over 60 or under 20years. * Conservative management (Non surgical)

Design outcomes

Primary

MeasureTime frameDescription
Power Doppler Vascular indices9 monthsThe ultrasonographic examination will provide data related to lesion size, lesion volume, uterine artery doppler indices and vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.
Uterine artery doppler indices in fibroids in relation to adenomyosis9 monthsUterine artery doppler indices(RI,PI) in fibroids in relation to adenomyosis

Countries

Egypt

Contacts

Primary ContactEman A. Elkattan, M.D,MRCOG
emyelkattan@gmail.com00201222854159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026