Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

Breast Fibroadenoma Clinical Trial

— HIFU-003  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03044054
• Other study ID #: HIFU/FA/003
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Theraclion
• Contact: Michel NUTA, MD
• Phone: 633404004
• Email: michel.nuta[@]theraclion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

Description:

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.

2. Diagnosis of fibroadenoma must be based on:

1. Clinical examination

2. Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.

3. Histologic confirmation by core needle biopsy.

3. Patient is a candidate for the surgery.

4. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.

5. The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.

6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.

7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).

8. Fibroadenoma is palpable.

9. Pain = 30mm/100mm measured on VAS as a maximum level during the last 30 days

10. Anxiety = 30mm/100mm measured on VAS as a maximum level during the last 30 days

11. Patient has signed a written informed consent.

Exclusion Criteria:

1. Patient is pregnant or nursing.

2. Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women > 35 years old, the diagnostic mammogram should be evaluated for calcification. In women = 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women = 35 years old will be excluded based on the findings of calcification on a single view mammogram.

3. Patient with history of breast cancer or history of laser or radiation therapy to the target breast.

4. Patient with breast implants in the target breast.

5. Patient with a breast cyst within the fibroadenoma to be treated.

6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.

7. Patient participating in another clinical trial involving an investigational drug, device or biologic.

Related Conditions & MeSH terms

• Breast Fibroadenoma
• Fibroadenoma

Intervention

Device:
• ECHOPULSE
HIFU Under ultrasound guidance

Locations

Country	Name	City	State
United States	University of Virginia Health system	Charlottesville	Virginia
United States	Bellevue Hospital Center	New York	New York
United States	Montefiore-Einstein Center for Cancer Care	New York	New York
United States	New York Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level assessment	visual analog scale	12 Months
Primary	Anxiety level assessment	visual analog scale	12 Months
Primary	Volume assessment	Ultrasound measurement	12 Months
Secondary	The short (6-item) version of the State-Trait Anxiety Inventory (STAI)		inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Secondary	Palpability of the breast fibroadenoma	Physician clinical examination	inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Secondary	Freedom from additional procedures for fibroadenoma of the breast	Physician assessment concerning the need of additional procedures	Day 2/3, Day 7, 6 months, 12 months
Secondary	Patient satisfaction	Self assessment satisfaction questionnaire	Month 6 and Months 12
Secondary	Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.	Assessment and capture of adverse events	Day 0, Day 2/3, Day 7, 6 months, 12 months