MyomaNCT00351494
Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
An observational study of Myoma, run by University Hospital, Tours at 1 site in France.
Trial summary
Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myoma
- What is being tested?
- contrast enhanced ultrasonography and embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women candidate for embolization of myomas
Who may be able to join
- Uterine myomas with solid tissue (greater diameter lower than 15 cm)
- The embolization is planified during the 15 days after the contrast ultrasonography
- Written informed consent is signed
Who cannot join
- Intracavitary uterine mass possibly due to a polyp or endometrial cancer
- Necessity of using the endovaginal way of ultrasonography because of the myoma's size and accessibility
- Menopause
- Pregnancy and breastfeeding
- Recent cardiac affection
- History of acute cardiac disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'Innovation Technologique-Ultrasons
Tours, 37344
Henri MARRET, Pr, (33) 2 47 47 82 59, marret@med.univ-tours.fr
Catherine ROUSSEL, ARC, (33) 2 47 47 97 89, roussel@med.univ-tours.fr
About this study
Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.
Read the detailed description
Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.
Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.
- Conditions
- Myoma
- Being tested
- contrast enhanced ultrasonography, embolization
- Keywords
- embolization, contrast enhanced ultrasound, myoma, uterine artery, microvascularisation
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced ultrasonographyProcedure or surgery
Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.
Abdominal route 2.4 ml sonovue per injection / bolus
embolizationProcedure or surgery
Intervention is described in the case report form for each patient
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization
Measured: Inclusion period and follow-up
Secondary outcomes (3)
Accordance between contrast-enhanced imaging and IRM
Measured: inclusion period and follow-up
Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month
Measured: inclusion period and follow-up
Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium
Measured: inclusion period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2006
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Henri MARRET, Pr, Principal investigator, Service de Gynécologie Obstétrique CHRU TOURSFrançois TRANQUART, Pr, Study director, Centre d'Innovation Technologique CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351494
- Sponsor's protocol ID
- HP06-HM/FIBROME
- Status last verified
- Nov 2007
- First submitted
- 12 Jul 2006
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Tranquart F, Brunereau L, Cottier JP, Marret H, Gallas S, Lebrun JL, Body G, Herbreteau D, Pourcelot L. Prospective sonographic assessment of uterine artery embolization for the treatment of fibroids. Ultrasound Obstet Gynecol. 2002 Jan;19(1):81-7. doi: 10.1046/j.0960-7692.2001.00535.x.
PubMed 11851974Marret H, Cottier JP, Alonso AM, Giraudeau B, Body G, Herbreteau D. Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG. 2005 Apr;112(4):461-5. doi: 10.1111/j.1471-0528.2004.00487.x.
PubMed 15777445Marret H, Tranquart F, Sauget S, Alonso AM, Cottier JP, Herbreteau D. Contrast-enhanced sonography during uterine artery embolization for the treatment of leiomyomas. Ultrasound Obstet Gynecol. 2004 Jan;23(1):77-9. doi: 10.1002/uog.944.
PubMed 14971005
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization
- ClinicalTrials.gov ID
- NCT00351494
- Acronym / sponsor ID
- HP06-HM/FIBROME
- Conditions
- Myoma
- Keywords
- embolization, contrast enhanced ultrasound, myoma, uterine artery, microvascularisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Jun 2009 (estimated)
- First posted
- 13 Jul 2006 (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.
Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.
Detailed description
Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.
Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women candidate for embolization of myomas
Key inclusion criteria (3 listed)
- Uterine myomas with solid tissue (greater diameter lower than 15 cm)
- The embolization is planified during the 15 days after the contrast ultrasonography
- Written informed consent is signed
Key exclusion criteria (6 listed)
- Intracavitary uterine mass possibly due to a polyp or endometrial cancer
- Necessity of using the endovaginal way of ultrasonography because of the myoma's size and accessibility
- Menopause
- Pregnancy and breastfeeding
- Recent cardiac affection
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 |
|---|---|---|
| contrast enhanced ultrasonographyThree contrast-enhanced ultrasonography : before embolization, after one day and after 6 months. Abdominal route 2.4 ml sonovue per injection / bolus | Procedure or surgery | – |
| embolizationIntervention is described in the case report form for each patient | Procedure or surgery | – |
Primary outcome
To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization
Time frame: Inclusion period and follow-up
3 secondary outcomes
Accordance between contrast-enhanced imaging and IRM
Time frame: inclusion period and follow-up
Accordance between early vascular patterns due to embolization of the fibroma and the success of the technique which is evaluated after 6 month
Time frame: inclusion period and follow-up
Relationship between the post embolization pain and the vascular change of the fibroma and the myometrium
Time frame: inclusion period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
- Background: PubMed 11851974Tranquart F, Brunereau L, Cottier JP, Marret H, Gallas S, Lebrun JL, Body G, Herbreteau D, Pourcelot L. Prospective sonographic assessment of uterine artery embolization for the treatment of fibroids. Ultrasound Obstet Gynecol. 2002 Jan;19(1):81-7. doi: 10.1046/j.0960-7692.2001.00535.x.
- Background: PubMed 15777445Marret H, Cottier JP, Alonso AM, Giraudeau B, Body G, Herbreteau D. Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG. 2005 Apr;112(4):461-5. doi: 10.1111/j.1471-0528.2004.00487.x.
- Background: PubMed 14971005Marret H, Tranquart F, Sauget S, Alonso AM, Cottier JP, Herbreteau D. Contrast-enhanced sonography during uterine artery embolization for the treatment of leiomyomas. Ultrasound Obstet Gynecol. 2004 Jan;23(1):77-9. doi: 10.1002/uog.944.
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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.
Henri MARRET, Pr principal investigator
Service de Gynécologie Obstétrique CHRU TOURS
François TRANQUART, Pr study director
Centre d'Innovation Technologique CHRU TOURS
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 Myoma, run by University Hospital, Tours at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Nov 2007. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henri MARRET, Pr ((33) 2 47 47 82 59, marret@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the usefulness of contrast-enhanced ultrasound with real-time imaging technique in the assessment of vascular patterns from myomas myometrium and ovaries before and after uterine artery embolization (time frame: Inclusion period and follow-up). 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 NCT00351494, which also lists 3 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 22 Nov 2007.