MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

NCT04345003 | Completed

• 1 other identifier: CHUBX 2018/35
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

Conditions

Uterine Fibroid

Keywords

HIFU; Fibroid treatment; MR elastography; Perfusion; Diffusion weighted imaging; ARFI; Fibroid stiffness

Outcome Measures

Primary Outcomes (1)

• Composite criteria

  Composite criteria measured from: * myoma stiffness (measured by Resoundant system) and * ablathermy efficiency.

  Baseline

Secondary Outcomes (6)

• leiomyoma stiffness measured by Resoundant system

  Baseline

• leiomyoma stiffness measured by ARFI-US

  Baseline

• clinical efficiency

  month 6

• inter-observer reproducibility

  Baseline

• leiomyoma perfusion

  Month 6

Study Arms (1)

Myoma elastography

EXPERIMENTAL

The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.

Device: Myoma elastography

Interventions

Myoma elastography DEVICE

The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.

Myoma elastography

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.
• Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
• Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
• SSS score on 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, gadolinium contrast injection (pregnancy etc..).
• Presence or suspicious of pelvic malignant tumor
• Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl)
• Pregnant or lactating woman
• Small submucous myoma accessible for hysteroscopic treatment.
• Active pelvic infection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 14, 2020
• Study Start: June 18, 2020
• Primary Completion: February 21, 2023
• Study Completion: August 31, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)