Uterine FibroidELASTUSNCT04345003
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
A study testing Myoma elastography in people with Uterine Fibroid, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- Myoma elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Normal cervicovaginal smear performed within 2 years prior to inclusion
Show all 10Show fewer
- 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
Who cannot join
- 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
- Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.
- Conditions
- Uterine Fibroid
- Being tested
- Myoma elastography
- Keywords
- HIFU, Fibroid treatment, MR elastography, Perfusion, Diffusion weighted imaging, ARFI, Fibroid stiffness
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoma elastographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Myoma elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria
Composite criteria measured from:
- myoma stiffness (measured by Resoundant system) and
- ablathermy efficiency.
Measured: Baseline
Secondary outcomes (6)
leiomyoma stiffness measured by Resoundant system
leiomyoma stiffness measured by Resoundant system
Measured: Baseline
leiomyoma stiffness measured by ARFI-US
leiomyoma stiffness measured by ARFI-US
Measured: Baseline
clinical efficiency
Defined as a decrease of 10pts on UFS-Qol score
Measured: month 6
inter-observer reproducibility
inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system
Measured: Baseline
leiomyoma perfusion
leiomyoma perfusion (diffusion)
Measured: Month 6
leiomyoma T2 signal
It will be evaluated in two ways:
The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki).
The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start18 Jun 2020
- Primary completion21 Feb 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345003
- Sponsor's protocol ID
- CHUBX 2018/35
- Other IDs
- 2019-A02963-54
- Acronym
- ELASTUS
- Status last verified
- Dec 2023
- First submitted
- 16 Mar 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
- ClinicalTrials.gov ID
- NCT04345003
- Acronym / sponsor ID
- ELASTUS / CHUBX 2018/35
- Conditions
- Uterine Fibroid
- Keywords
- HIFU, Fibroid treatment, MR elastography, Perfusion, Diffusion weighted imaging, ARFI, Fibroid stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myoma elastography | Experimental | Device: Myoma elastographyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myoma elastographyThe 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 |
Primary outcome
Composite criteria
Time frame: Baseline
Composite criteria measured from: * myoma stiffness (measured by Resoundant system) and * ablathermy efficiency.
6 secondary outcomes
leiomyoma stiffness measured by Resoundant system
Time frame: Baseline
leiomyoma stiffness measured by ARFI-US
Time frame: Baseline
clinical efficiency
Time frame: month 6
inter-observer reproducibility
Time frame: Baseline
leiomyoma perfusion
Time frame: Month 6
leiomyoma T2 signal
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myoma elastography in people with Uterine Fibroid, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite criteria (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.