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

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

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Masses
• Intervention / Treatment: Other: Three dimensional Power Doppler to the myometrial mass; Other: Uterine artery Doppler

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power Doppler Vascular indices	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.	9 months
Uterine artery doppler indices in fibroids in relation to adenomyosis	Uterine artery doppler indices(RI,PI) in fibroids in relation to adenomyosis	9 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: Protocol200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No