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

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Eduardo Zlotnik, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01468402
First received: October 23, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
Exposure to Magnetic Field
Uterine Leiomyoma
Procedure: Magnetic Resonance Image

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • Leiomyoma reduction in patients who underwent uterine artery embolization [ Time Frame: One month before(baseline) and six month after the embolization ] [ Designated as safety issue: No ]
    Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization


Enrollment: 50
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Magnetic Resonanse 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 fibroid, and their location in the myometrium was classified. Perfusion and the characterization of the T2 signal were also evaluated.
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.
Other Names:
  • Magnetic Resonance Image with a high-field scanner
  • Siemens Magnetom 3-Tesla

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women from the Leiomyoma Service, with eligible criteria and chose this kind of treatment between september 2008 and march 2009.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01468402

Locations
Brazil
Hospital Israelita Albert Einstein
São Paulo, SP, Brazil, 05652 - 900
Sponsors and Collaborators
Hospital Israelita Albert Einstein
University of Sao Paulo
Investigators
Principal Investigator: Eduardo Zlotnik Hospital Israelita Albert Einstein
  More Information

Publications:
Responsible Party: Eduardo Zlotnik, Principal Investigator, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01468402     History of Changes
Other Study ID Numbers: HIAE
Study First Received: October 23, 2011
Last Updated: November 8, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Israelita Albert Einstein:
Leiomyoma
uterine artery embolization
magnetic resonance imaging

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 28, 2014