Oxytocin in MRI-HIFU

Phase 4

• Conditions: Fibroid; Adenomyosis
• Interventions: Drug: Oxytocin

• Registration Number: NCT03937401
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-26
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-02
• Last Update Submitted: 2019-05-02
• Study First Posted: 2019-05-03
• Last Update Posted: 2019-05-03
• Primary Completion: 2019-12-30
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with oxytocin during MRI-HIFU	Oxytocin	-

Primary Outcome Measures

Name	Time	Method
UFS-Qol	12 months after HIFU treatment	Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
NPV	up to one year	non perfused volume (percentage of fibroid destroyed)
duration of MRI-HIFU	up to one year	duration of MRI-HIFU treatment

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland