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