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The Use of Doppler to Diagnose Myometrial Masses (3D)

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ClinicalTrials.gov Identifier: NCT01833871
Recruitment Status : Unknown
Verified April 2013 by Eman Elkattan, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 17, 2013
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Eman Elkattan, Cairo University

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.

Condition or disease Intervention/treatment Phase
Uterine Masses Other: Three dimensional Power Doppler to the myometrial mass Other: Uterine artery Doppler Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Uterine Artery Doppler and Three Dimensional Power Doppler in the Diagnosis of Myometrial Masses
Study Start Date : February 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: myometrial fibroid/adenomyoma
Patients scheduled for myomectomy or hysterectomy with preoperative diagnosis of uterine myoma, adenomyosis or both by ultrasound .Trans-vaginal 3D power Doppler and uterine artery doppler will be done for all participants prior to surgery.
Other: Three 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.

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




Primary Outcome Measures :
  1. Power Doppler Vascular indices [ Time Frame: 9 months ]
    The 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.

  2. Uterine artery doppler indices in fibroids in relation to adenomyosis [ Time Frame: 9 months ]
    Uterine artery doppler indices(RI,PI) in fibroids in relation to adenomyosis



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833871


Contacts
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Contact: Eman A. Elkattan, M.D,MRCOG 00201222854159 emyelkattan@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Sponsors and Collaborators
Cairo University

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Responsible Party: Eman Elkattan, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT01833871     History of Changes
Other Study ID Numbers: Protocol200
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013