NCT03742401

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Theraclion · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

Detailed description

Fibroadenomas are well-circumscribed benign tumors, easily distinguishable from adjacent normal breast tissue on ultrasound images. The goal of this protocol is to compare HIFU and surgery in terms of cost, safety, and clinical effectiveness for the treatment of nonmalignant breast tumors. Fibroadenomas appear to be an ideal target for evaluation of ultrasound guided HIFU treatment. However, not all the FA are suitable for surgical treatment and in many cases surveillance associated or not with hormonal medication may be sufficient for limiting the symptoms at the degree compatible with a good quality of life for the patients. In addition, from the fraction of the patients for which ablation is a genuine medical need due to the severity of the pathology (size, symptoms, disturbed daily activity with possible psychological impact), only a part of them are suitable for undergoing the HIFU treatment. Therefore, all the patients to be included in this study have an initial indication of surgical resection of the adenoma. Unlike the patients presenting FA and suitable for medication and surveillance, the cases for which surgery is an indication are symptomatic (significant pain, discomfort, anxiety) and/or are presenting a growth observed during their surveillance with ultrasound examination. In addition, all the eligible patients will have to comply with the technical limitations of the HIFU method in terms of lump size, subcutaneous depth, presence of calcifications and other contraindications like presence of breast implants or under areolar location. Knowing that after the age of 45 years the lumps are in many institutions reserved exclusively for surgery in order to eliminate all suspicion of malignancy, the upper age limit is fixed at 45. Further limitations as established by the American Society of Breast Surgeons for potential candidates of percutaneous excision will be added as inclusion criteria for all patients (the lesion must be sonographically visible, the diagnosis of FA must be confirmed histologically, lesions should be less than 4cm in largest diameter).

Conditions

• Breast Fibroadenoma

Interventions

Type	Name	Description
PROCEDURE	Surgery	Traditional open excisional surgery
DEVICE	HIFU (Echopulse)	High intensity focused ultrasound (HIFU) non invasive intervention

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2018-11-15
• Last updated: 2020-03-16

Locations

12 sites across 1 country: France