Factors Influencing Volumetric MR-HIFU Ablation of Uterine Fibroids

NCT02386137 | Completed

• 1 other identifier: CHUBX 2014/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume). The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.

Conditions

Uterine Fibroid

Keywords

MR-HIFU; HIFU; Fibroid treatment; MR Perfusion; CEUS perfusion; Diffusion weighted imaging; ARFI; Fibroid stiffness

Outcome Measures

Primary Outcomes (1)

• Ablathermy efficiency.

  necrosis tumor volume / total volume ratio

  2 months after inclusion

Secondary Outcomes (3)

• Thermal parameters

  2 months after inclusion

• Fibroid signal intensity ratio on T2.

  At inclusion and 2 months after inclusion

• Fibroids perfusion data computed with MR perfusion

  At inclusion

Study Arms (1)

Patient

EXPERIMENTAL

Woman aged more than 18 years having one or two symptomatic fibroid with size \< 15cm.

Device: Contrast-enhancement ultrasound with Sonovue

Interventions

Contrast-enhancement ultrasound with Sonovue DEVICE

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman
• Aged more than 18 years
• Not postmenopausal
• Having one or two symptomatic fibroid with size \< 15cm.
• Symptoms Severity Score (SSS) score on Uterine Fibroid Symptoms related Quality of Life (UFS-Qol) ≥ 10
• Signed informed consent prior to any study related procedure
• With a medical insurance

You may not qualify if:

• Contraindicated to MR examination, SONOVUE and gadolinium contrast injection (pregnancy etc..).
• Presence or suspicious of pelvic malignant tumor

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service d'imagerie médicale

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Antoine BENARD, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 11, 2015
• Study Start: July 22, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

FR (1)