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Oxytocin in MRI-HIFU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03937401
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fibroid Adenomyosis Drug: Oxytocin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Oxytocin in MRI-HIFU Treatment
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Patients treated with oxytocin during MRI-HIFU Drug: Oxytocin
Oxytocin infusion during MRI-HIFU treatment
Other Name: MRI-HIFU




Primary Outcome Measures :
  1. NPV [ Time Frame: up to one year ]
    non perfused volume (percentage of fibroid destroyed)

  2. duration of MRI-HIFU [ Time Frame: up to one year ]
    duration of MRI-HIFU treatment

  3. UFS-Qol [ Time Frame: 12 months after HIFU treatment ]
    Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937401


Locations
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Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03937401     History of Changes
Other Study ID Numbers: T366/2017
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers

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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

Keywords provided by Turku University Hospital:
oxytocin
MRI-HIFU
fibroid
adenomyosis

Additional relevant MeSH terms:
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Leiomyoma
Adenomyosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Diseases
Genital Diseases, Female
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs