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Completed

NCT Number: NCT01468402

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

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

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Key information

Conditions

Exposure to Magnetic Field Connective Tissue Diseases Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases Uterine Leiomyoma

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652 - 900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Image

Procedure

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

Primary outcomes

  1. Leiomyoma reduction in patients who underwent uterine artery embolization

    Time frame: One month before(baseline) and six month after the embolization

    Use the magnetic resonanse to evaluate factors that predicted leiomyoma reduction in patients who underwent uterine artery embolization

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • University of Sao Paulo

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 9, 2011
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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