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Trial · Interventional

WithdrawnPhase 3Registry data

Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

NCTNCT02736435 (opens ClinicalTrials.gov in a new tab)Other idRP-317-07302014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 3
Enrollment
0 participants (actual)
Sponsor
Thunder Bay Regional Health Research Institute · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Canada

Start
18 Jan 2018
Primary completion
18 Jan 2018
Completion
18 Jan 2018
First posted
13 Apr 2016 (estimated)
Last update posted
6 Feb 2018
Conditions
Uterine Leiomyoma

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019
  1. Ph 3

    Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

    NCT02736435

    18 Jan 2018 to 18 Jan 2018

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of uterine fibroids in Northwestern Ontario, which is a rural and remote setting.

Interventions

  • Magnetic Resonance Guided High Intensity Focused UltrasoundDevice
  • leuprolide acetate for depot suspensionDrug

Arms2

  • Experimental

    Fibroid dimension < 8 cm

    Women with a maximum fibroid dimension less than 8 cm and a total uterine volume less than 900 cc. Intervention: Treatment of fibroids with Magnetic Resonance Guided High Intensity Focused Ultrasound.

  • Experimental

    Fibroid dimension > 8 cm

    Women with a maximum fibroid dimension greater than 8 cm or a total uterine volume greater than 900 cc. Intervention A: Pre-treated with 11.25mg leuprolide acetate for depot suspension for 3 months to reduce size of fibroids. Intervention B: Treatment with Magnetic Resonance Guided High Intensity Focused Ultrasound if fibroids decrease to treatable size of less than 8cm and uterine volume less than 900cc.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in uterine fibroid symptom severity scale

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

Secondary outcomes(8)

  1. Change in short form McGill pain questionnaire

    Time frame · 24h, 72h, 6week, 3, 6, and 12 month

    Registry description

    Assessing change from baseline value

  2. Change in pictorial blood loss assessment chart

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

  3. Change in uterine fibroid symptom and health-related quality of life questionnaire

    Time frame · 12 months

    Registry description

    Assessing change from baseline value

  4. Participant use of alternative therapies for treatment of fibroids

    Time frame · 6 weeks, 3, 6, and 12 months

    Registry description

    Questionnaire to assess if participants are selecting to use alternative treatments for relief of symptoms of uterine fibroids.

  5. MR Imaging to assess change in fibroid volume.

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

  6. MR Imaging to assess change in perfusion.

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

  7. Ultrasound imaging to assess change in fibroid volume.

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

  8. Ultrasound imaging to assess change in fibroid perfusion.

    Time frame · 3, 6, and 12 months

    Registry description

    Assessing change from baseline value

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1991

8 results

Treatment of leiomyomata uteri with leuprolide acetate depot: a double-blind, placebo-controlled, multicenter study. The Leuprolide Study Group.

Friedman et al. 1991Obstetrics and gynecologycited by 112

PMID 1901638PUB-01901638

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women aged 18 to 50 years * Weight \<140kg * Pre or perimenopausal * Uterine size \<24 weeks * Cervical screen by Pap test: Normal, Low Grade Squamous Intraepithelial Lesion, or Atypical Squamous Cells of Undetermined Significance as per Cancer Care Ontario guidelines * Transformed symptom severity score ≥40 * Willing to attend all study visits * Willing to complete evaluation forms * Willing and able to use reliable contraception; MR-HIFU Criteria Trial Arm 1: * Minimum of 50% of fibroid volume accessible for treatment * Dominant fibroid ≤8 cm * Uterine volume \<900 cc * Total fibroid treatment volume \<250 cc * No more than 5 fibroids planned for ablation * Completely non-enhancing fibroids should not be treated MR-HIFU Criteria Trial Arm 2: * Minimum of 50% of fibroid volume accessible for treatment * Dominant fibroid \>8 cm or uterine volume \>900 cc * Total fibroid treatment volume \<250 cc * No more than 5 fibroids planned for ablation * Completely non-enhancing fibroids should not be treated Exclusion Criteria: * Other pelvic disease (endometriosis, ovarian tumor, acute pelvic disease, other mass) * Significant systemic disease even if well controlled * Positive pregnancy test * Abnormal uterine bleeding (participant can be included if an endometrial biopsy confirms no hyperplasia or malignancy in the past 6 months) * Extensive scarring along anterior abdominal wall (\>50% of area) * Surgical clips or scar tissue in the path of the MR-HIFU beam * MRI contraindicated according to standard operating procedure * MRI contrast contraindicated (including renal insufficiency) * Calcifications around or throughout uterine tissues * Fibroids not quantifiable on MRI * Highly perfused or brighter than myometrium in T2-weighted MRI fibroids (Type 3 fibroids).

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