NCT01468402

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

7 months

First QC Date

October 23, 2011

Last Update Submit

November 8, 2011

Conditions

Exposure to Magnetic FieldUterine Leiomyoma

Keywords

Leiomyomauterine artery embolizationmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Magnetic Resonance ImagePROCEDURE

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.

Also known as: Magnetic Resonance Image with a high-field scanner, Siemens Magnetom 3-Tesla
Magnetic Resonanse Image

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652 - 900, Brazil

Location

Related 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.

    PMID: 20305945BACKGROUND

  • 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. doi: 10.1590/s0100-72032010001100003. Portuguese.

    PMID: 21271163BACKGROUND

MeSH Terms

Conditions

MyofibromaLeiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeoplasms, Muscle Tissue

Study Officials

  • Eduardo Zlotnik

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2011

First Posted

November 9, 2011

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

August 1, 2009

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

BR(1)