An interventional study of High Instensity Focused Ultrasound in Breast Cancer Female, sponsored by Institut Bergonié. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Institut Bergonié · Not applicable, Interventional, and Other
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Among 29 studies in Breast Neoplasms by Institut Bergonié — 4 open to participants now, 6 under way, none of them phase 3. Breast Neoplasms · Institut Bergonié.
Among the 29 studies in Breast Neoplasms by Institut Bergonié, this one is the 18th largest by planned enrollment of the 20 interventional ones that give a count, is the only one that started in 2018, is one of 16 with no phase, and was the 20th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →4 of the 29 studies in Breast Neoplasms by Institut Bergonié are open now, in 1 country. Recruiting first, the newest first:
Institut Bergonié · Sites in France
Ages 15–49
Institut Bergonié · Sites in France
Ages 18+ · Women only
Institut Bergonié
Ages 18–50 · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2
First in 1990; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 87 across the 20 interventional studies, 149 across the 8 observational. Of the 18 that completed or were terminated, 14 (78%) have results posted.
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Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
1 of the studies in Breast Neoplasms by Institut Bergonié that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07425548Institut BergoniéEvaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer. | 2027-07 |
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Among the 29 studies in Breast Neoplasms by Institut Bergonié, from their registry updates:
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Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.
Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).
The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.
Indication :
Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.
Course of the study :
Number of patients :
15 patients will be included in this pilot study. If no success is observed, the study will be stopped and the technique considered inefficient. If there are one or more successes, an Independant Data Monitoring Committee (IDMC) will meet to propose an additional trial if necessary with the data from this trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High Intensity Focused Ultrasound for the treatment of breast tumors, guided by MRI
Device: High Instensity Focused Ultrasound
High Intensity Focused Ultrasound guided by MRI
Also known as: HIFU
Efficacy of HIFU for the treatment of breast tumors, based on histological criteria
* Complete success: absence of viable invasive tumor cells on histological analysis. * Incomplete success: Partial tumor destruction of the invasive contingent, unhealthy margins due to underestimation of tumor volume before treatment or imperfect targeting of focused ultrasound. Incomplete successes will be considered as failures. The persistence of an in situ quota alone will be considered as success. * Failure: presence of viable invasive tumor cells in the treated area.
Time frame: Day 30
Feasibility of non-invasive pre-surgical identification of the tumor area to be resected (palpation by the surgeon of the focused ultrasound ablation zone)
Time frame: Day 2, 8
Immediate complications of focused ultrasound
Time frame: Day 30
Pain (visual analogue scale) experienced by patients during the sedation procedure, until surgery.
Time frame: Day 0, 2
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2018 (actual). Primary completion is estimated for Jun 2026, 96 months after the start.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 96 months is above that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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