Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

NCT03044054 | Completed DMC

• 1 other identifier: HIFU/FA/003
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Fibroadenoma

Keywords

HIFU

Outcome Measures

Primary Outcomes (3)

• Pain level assessment

  visual analog scale

  12 Months

• Anxiety level assessment

  visual analog scale

  12 Months

• Volume assessment

  Ultrasound measurement

  12 Months

Secondary Outcomes (5)

• The short (6-item) version of the State-Trait Anxiety Inventory (STAI)

  inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months

• Palpability of the breast fibroadenoma

  inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months

• Freedom from additional procedures for fibroadenoma of the breast

  Day 2/3, Day 7, 6 months, 12 months

• Patient satisfaction

  Month 6 and Months 12

• Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.

  Day 0, Day 2/3, Day 7, 6 months, 12 months

Study Arms (1)

ECHOPULSE

EXPERIMENTAL

ECHOPULSE HIFU

Device: ECHOPULSE

Interventions

ECHOPULSE DEVICE

HIFU Under ultrasound guidance

ECHOPULSE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
• Diagnosis of fibroadenoma must be based on:
• Clinical examination
• 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.
• Histologic confirmation by core needle biopsy.
• Patient is a candidate for the surgery.
• 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.
• 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.
• 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.
• 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).
• Fibroadenoma is palpable.
• Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
• Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
• Patient has signed a written informed consent.

You may not qualify if:

• Patient is pregnant or nursing.
• 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.
• Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
• Patient with breast implants in the target breast.
• Patient with a breast cyst within the fibroadenoma to be treated.
• Patient participating in another clinical trial involving an investigational drug, device or biologic.

Sponsors & Collaborators

• Theraclion: lead

Study Sites (4)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

New York Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore-Einstein Center for Cancer Care

New York, New York, United States

Location

University of Virginia Health system

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Officials

• Michel NUTA, MD

  Theraclion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 6, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)