Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

Uterine Leiomyoma Clinical Trial

Official title:

Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468402
• Other study ID #: HIAE
• Status: Completed
• Phase: N/A
• First received: October 23, 2011
• Last updated: November 8, 2011
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2011
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.

Description:

This study followed symptomatic premenopausal women with uterine leiomyoma who underwent uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of both the volume of the entire uterus and the leiomyomas one month before and six months after UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study, the investigators examined 179 leiomyomas in 50 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• ultrasound diagnosis of uterine leiomyoma

• presence of symptoms (menorrhalgia and/or pelvic pain)

• indication for UAE(the desire to keep the uterus and/or contraindications for surgery).

Exclusion Criteria:

• malignant genital neoplasms

• pelvic inflammatory disease

• allergy to iodinated contrast

• coagulopathy, renal failure

• vasculitis

• pelvic irradiation

• pregnancy

• subserosal leiomyoma with a pedicle smaller than 50% of diameter of the fibroid.

Related Conditions & MeSH terms

• Exposure to Magnetic Field
• Leiomyoma
• Uterine Leiomyoma

Intervention

Procedure:
• Magnetic Resonance Image
The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Affonso BB, Nasser F, de Jesus Silva SG, Silva MC, Zlotnik E, de Lorenzo Messina M, Baracat EC. [Strategies for reduction of exposure to ionizing radiation in women undergone to uterine fibroid embolization]. Rev Bras Ginecol Obstet. 2010 Feb;32(2):77-81. Portuguese. — View Citation

Nasser F, Affonso BB, de Jesus-Silva SG, Coelho Dde O, Zlotnik E, Messina Mde L, Baracat EC. [Uterine fibroid embolization in women with giant fibroids]. Rev Bras Ginecol Obstet. 2010 Nov;32(11):530-5. Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leiomyoma reduction in patients who underwent uterine artery embolization	Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization	One month before(baseline) and six month after the embolization