Treatment of Breast Fibroadenoma Targeted Tissue With HIFU (HIFU-003)

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Fibroadenoma
• Intervention / Treatment: Device: ECHOPULSE

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel NUTA, MD; Phone Number: 633404004; Email: michel.nuta@theraclion.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Bellevue Hospital Center
      • Contact: Jocelyn Acosta
      • Principal Investigator: Kathie-Ann Joseph, Prof
      • Sub-Investigator: Chloe Chhor, Dr
      • Sub-Investigator: Shubhada Dhage, Dr
    • New York, New York, United States, 10032
      • Recruiting
      • New York Columbia University Medical Center
      • Contact: Amanda Alonso
      • Principal Investigator: Margaret Chen-Seetoo, Dr
    • New York, New York, United States
      • Not yet recruiting
      • Montefiore-Einstein Center for Cancer Care
      • Contact: Prena Etchen
      • Principal Investigator: REIG Beatriu, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia Health System
      • Contact: Katie Rea
      • Principal Investigator: David Brenin, Prof
      • Sub-Investigator: Carrie Rochmann, Dr
      • Sub-Investigator: Jonathon Nguyen, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECHOPULSE; ECHOPULSE HIFU	Device: ECHOPULSE; HIFU Under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level assessment	visual analog scale	12 Months
Anxiety level assessment	visual analog scale	12 Months
Volume assessment	Ultrasound measurement	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Physician clinical examination	inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
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
Patient satisfaction	Self assessment satisfaction questionnaire	Month 6 and Months 12
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

Collaborators and Investigators

• Sponsor: Theraclion
• Investigators: Study Director: Michel NUTA, MD, Theraclion

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimated): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIFU
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Fibroepithelial; Fibroadenoma
• Other Study ID Numbers: HIFU/FA/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO