Clinical trial · Interventional
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
NCT01331954CI-TRIAL-00075919unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
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
- HIFU
- interventionNames
- Device: Ultrasonic ablation device
Primary outcomes (1)
- measure
- Reduction of breast fibroadenoma volume at ultrasonography
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * One breast fibroadenoma with diagnosis based on: * Clinical examination * Ultrasound image * For women older than 35 years: mammogram with BI-RADS score \< 3 * Histologic confirmation by two independent readers * Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound) Exclusion Criteria: * Patient pregnant or lactating * Bi-RADS score \> 2 at the mammogram, or microcalcifications within the lesion. * History of breast cancer or history of laser or radiation therapy to the target breast * Breast implants * Breast cyst * Fibroadenoma not clearly visible on the ultrasound images (in B mode) * Patient participating in other trials using drugs or devices
References
Publications (1)
- DERIVEDKovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017. PMID 28331611