Oxytocin in MRI-HIFU

May 2, 2019 updated by: Turku University Hospital

Use of Oxytocin in MRI-HIFU Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients treated with oxytocin during MRI-HIFU
Drug: Oxytocin
Oxytocin infusion during MRI-HIFU treatment
Other Names:
  • MRI-HIFU

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T366/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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