Exposure to Magnetic FieldNCT01468402
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
An observational study of Exposure to Magnetic Field and Uterine Leiomyoma, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Exposure to Magnetic Field, Uterine Leiomyoma
- What is being tested?
- Magnetic Resonance Image
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women from the Leiomyoma Service, with eligible criteria and chose this kind of treatment between september 2008 and march 2009.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652 - 900
About this study
The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.
Read the 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.
- Conditions
- Exposure to Magnetic Field, Uterine Leiomyoma
- Being tested
- Magnetic Resonance Image
- Keywords
- Leiomyoma, uterine artery embolization, magnetic resonance imaging
- Medical subject headings
- Myofibroma, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImageProcedure or surgery
Also called Magnetic Resonance Image with a high-field scanner, Siemens Magnetom 3-Tesla
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Magnetic Resonance Image |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month before(baseline) and six month after the embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exposure to Magnetic FieldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Eduardo Zlotnik, Hospital Israelita Albert Einstein
- Investigators
- Eduardo Zlotnik, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468402
- Sponsor's protocol ID
- HIAE
- Status last verified
- Nov 2011
- First submitted
- 23 Oct 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20305945Nasser 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.
PubMed 21271163
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
- ClinicalTrials.gov ID
- NCT01468402
- Acronym / sponsor ID
- HIAE
- Conditions
- Exposure to Magnetic Field, Uterine Leiomyoma
- Keywords
- Leiomyoma, uterine artery embolization, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonanse Image | – | Procedure: Magnetic Resonance ImageThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women from the Leiomyoma Service, with eligible criteria and chose this kind of treatment between september 2008 and march 2009.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- malignant genital neoplasms
- pelvic inflammatory disease
- allergy to iodinated contrast
- coagulopathy, renal failure
- vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImageAlso: Magnetic Resonance Image with a high-field scanner, Siemens Magnetom 3-TeslaThe 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. | Procedure or surgery | Magnetic Resonanse Image |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
- Background: PubMed 20305945Affonso 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.
- Background: PubMed 21271163Nasser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Zlotnik principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Magnetic Field and Uterine Leiomyoma, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leiomyoma reduction in patients who underwent uterine artery embolization (time frame: One month before(baseline) and six month after the embolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.