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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00248820 |
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Date of registration:
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02/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses
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Scientific title:
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Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00248820 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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François Tranquart, PR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre d'Innovation Technologique - CHRU Tours |
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Name:
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Henri Marret, PR |
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Address:
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Telephone:
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(33) 0 47 47 82 59 |
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Email:
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marret@med.univ-tours.fr |
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Affiliation:
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Name:
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Henri Marret, PR |
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Address:
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Telephone:
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(33) 0 47 47 82 59 |
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Email:
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marret@med.univ-tours.fr |
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Affiliation:
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Name:
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Henri Marret, PR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age or older
- Patient with adnexal mass detected by ultrasound
- Any programmed surgery
Exclusion Criteria:
- Any contraindication to surgery
- Injection of another contrast agent within 24 hours before the study examination
- Pregnancy, breastfeeding
- Patient known to have a coronary syndrome
- Unstable angina and myocardial infarction
- Acute cardiac failure, Class III/IV cardiac failure
- Severe rhythm disorders
- Acute endocarditis
- Prosthetic valves
- Patient previously having received an investigational drug within 30 days prior to
admission into this study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Tumor
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Intervention(s)
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Procedure: Contrast-enhanced ultrasound
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Primary Outcome(s)
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From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time
[Time Frame: inclusion period]
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Secondary Outcome(s)
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Histology assessments: microvessel density assessments and histological diagnosis
[Time Frame: inclusion period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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