Back to resultsOxytocin in MRI-HIFU
Primary Purpose
Fibroid, Adenomyosis
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Fibroid focused on measuring oxytocin, MRI-HIFU, fibroid, adenomyosis
Eligibility 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
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients treated with oxytocin during MRI-HIFU
Arm Description
Outcomes
Primary Outcome Measures
NPV
non perfused volume (percentage of fibroid destroyed)
duration of MRI-HIFU
duration of MRI-HIFU treatment
UFS-Qol
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03937401
Brief Title
Oxytocin in MRI-HIFU
Official Title
Use of Oxytocin in MRI-HIFU Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid, Adenomyosis
Keywords
oxytocin, MRI-HIFU, fibroid, adenomyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with oxytocin during MRI-HIFU
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
MRI-HIFU
Intervention Description
Oxytocin infusion during MRI-HIFU treatment
Primary Outcome Measure Information:
Title
NPV
Description
non perfused volume (percentage of fibroid destroyed)
Time Frame
up to one year
Title
duration of MRI-HIFU
Description
duration of MRI-HIFU treatment
Time Frame
up to one year
Title
UFS-Qol
Description
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Time Frame
12 months after HIFU treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers
Citations:
PubMed Identifier
33207939
Citation
Otonkoski S, Sainio T, Komar G, Suomi V, Saunavaara J, Blanco Sequeiros R, Perheentupa A, Joronen K. Oxytocin selectively reduces blood flow in uterine fibroids without an effect on myometrial blood flow: a dynamic contrast enhanced MRI evaluation. Int J Hyperthermia. 2020;37(1):1293-1300. doi: 10.1080/02656736.2020.1846792.
Results Reference
derived
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Oxytocin in MRI-HIFU
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