Clinical trial · Interventional
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU). This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Fibroadenoma | Breast Fibroadenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasonic ablation device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Intensity Focused Ultrasound (HIFU)
- interventionNames
- Device: Ultrasonic ablation device
Primary outcomes (1)
- measure
- HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
- timeFrame
- 6 months after HIFU treatment
Secondary outcomes (3)
- measure
- Volume reduction of the fibroadenoma
- timeFrame
- 12 months after HIFU treatment
- description
- reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology * Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound) Exclusion Criteria: * Patient pregnant or lactating * Microcalcifications within the lesion at the mammogram. * History of breast cancer or history of laser or radiation therapy to the target breast * Breast implant in the target breast. * Fibroadenoma not clearly visible on the ultrasound images (in B mode) * Patient participating in other trials using drugs or devices
References
Publications (0)
Data not yet available