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Sponsored by: |
University Hospital, Tours |
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Information provided by: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT00351494 |
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.
Condition | Intervention |
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Myoma |
Procedure: contrast enhanced ultrasonography Procedure: embolization |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization |
Estimated Enrollment: | 40 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | June 2009 |
Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.
Abdominal route 2.4 ml sonovue per injection / bolus
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women candidate for embolization of myomas
Inclusion Criteria:
Exclusion Criteria:
Contact: Henri MARRET, Pr | (33) 2 47 47 82 59 | marret@med.univ-tours.fr |
Contact: Catherine ROUSSEL, ARC | (33) 2 47 47 97 89 | roussel@med.univ-tours.fr |
France | |
Centre d'Innovation Technologique-Ultrasons | Recruiting |
TOURS, France, 37344 | |
Contact: Henri MARRET, Pr (33) 2 47 47 82 59 marret@med.univ-tours.fr | |
Contact: Catherine ROUSSEL, ARC (33) 2 47 47 97 89 roussel@med.univ-tours.fr | |
Sub-Investigator: François TRANQUART, Pr | |
Sub-Investigator: Aurore BLEUZEN, MD | |
Sub-Investigator: Denis HERBRETEAU, Pr | |
Sub-Investigator: Marc LEGEAIS, MD | |
Sub-Investigator: Nathalie WAGNER, MD |
Principal Investigator: | Henri MARRET, Pr | Service de Gynécologie Obstétrique CHRU TOURS |
Study Director: | François TRANQUART, Pr | Centre d'Innovation Technologique CHRU TOURS |
Study ID Numbers: | HP06-HM/FIBROME |
Study First Received: | July 12, 2006 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00351494 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
embolization contrast enhanced ultrasound myoma uterine artery microvascularisation |
Neoplasms, Connective and Soft Tissue Myoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type |