Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma

Introduction High-intensity-focused ultrasound (HIFU) is a safe and feasible treatment option for breast fibroadenoma. However, its learning curve has not been described in the medical literature. Methods All patients with biopsy-proven fibroadenoma considered indicated for HIFU were screened for eligibility for HIFU treatment. A total of 60 patients were recruited according to the pre-defined sample size calculation. Results Sixty consecutive patients were divided into three cohorts in chronological order. The mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 6 months post-HIFU ablation were 38%, 34%, and 59%, respectively. Significant tumor shrinkage was observed from case 41 onward (p < 0.0001). Similarly, the mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 12 months post-HIFU ablation were 45%, 51%, and 71%, respectively. Significant tumor shrinkage was observed from case 41 onwards (p < 0.0473). The mean procedure time for the first 20 patients was 48.5 (range 45-75) minutes, while that in the second 20 patients was 39.7 (range 20-60) minutes, and that in the last 20 patients was 28.9 (range 15-45) minutes. The treatment time was significantly shorter from case 41 onwards (p = 0.0481). Conclusion Treatment outcomes and treatment time improved significantly after performing approximately 40 HIFU procedures.

Automated summary

The study found that treatment outcomes and treatment time for breast fibroadenoma significantly improved after approximately 40 HIFU procedures.