Oxytocin in MRI-HIFU
Overview
Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.
Full Title of Study: “Use of Oxytocin in MRI-HIFU Treatment”
Study Type
- Study Type: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 30, 2019
Interventions
- Drug: Oxytocin
- Oxytocin infusion during MRI-HIFU treatment
Arms, Groups and Cohorts
- Experimental: Patients treated with oxytocin during MRI-HIFU
Clinical Trial Outcome Measures
Primary Measures
- NPV
- Time Frame: up to one year
- non perfused volume (percentage of fibroid destroyed)
- duration of MRI-HIFU
- Time Frame: up to one year
- duration of MRI-HIFU treatment
- UFS-Qol
- Time Frame: 12 months after HIFU treatment
- Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Participating in This Clinical Trial
Inclusion Criteria
- Patients undergoing MRI-HIFU -treatment
- Patients assessed for suitability to MRI-HIFU treatment
- willingness to participate in trial
Exclusion Criteria
- Known allergy to Syntocinon/oxytocin
- Elevated blood pressure
- ischemic heart disease
- Long QT- interval
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Turku University Hospital
- Provider of Information About this Clinical Study
- Sponsor
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