CompletedNot Applicable

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

France40 participantsStarted 2020-06-18

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite criteria

Timeframe: Baseline

Trial details

NCT IDNCT04345003

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-21

View on ClinicalTrials.gov More Uterine Fibroid trials