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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.