NCT02633254

Brief Summary

So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power sonications (heating points) will be used to occlude (part of) the feeding vessels of the fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the bulk volume of the fibroid can be treated using the standard approach.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

November 19, 2015

Last Update Submit

April 6, 2017

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (2)

  • Time to peak

    The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid. The perfusion will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months, i.e. the time to peak values. Data will be analyzed using Philips IntelliSpace Portal.

    three months

  • Regional Blood volume

    The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid and the possibly related adverse events. The perfusion will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months, i.e. regional blood volumes (area under the curve). Data will be analyzed using Philips IntelliSpace Portal.

    Three months

Secondary Outcomes (1)

  • Adverse effects

    Three months

Study Arms (1)

Single arm

EXPERIMENTAL

Treatment group Magentic Resonance guided High Intensity Focused Ultrasound will be employed on uterine fibroids

Device: Magnetic Resonance guided High Intensity Focused Ultrasound

Interventions

Magnetic Resonance guided High Intensity Focused UltrasoundDEVICE

Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound

Single arm

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent;
  • A type 3 uterine fibroid;
  • Sufficient physical condition to undergo deep sedation;
  • Waist circumference that allows positioning on the HIFU table top inside the MR bore.

You may not qualify if:

  • Contra-indication for MRI scanning according to the hospital guidelines;
  • Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR \<30 mL/min/1.73 m2);
  • Surgical clips or considerable scar tissue in the HIFU beam path;
  • A total of more than ten fibroids;
  • Post- or peri-menopausal status;
  • Fibroid size \>10 cm in diameter;
  • Patient has an active pelvic infection;
  • Patient has an undiagnosed pelvic mass outside the uterus;
  • Patient who is not able to tolerate the required stationary prone position during treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Maurice van den Bosch, Prof Dr

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 17, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)