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

NCT03022695 | Completed

• 1 other identifier: HIFU 1.0
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (1)

• The efficacy is assessed by a reduction in volume of the fibroadenoma at baseline, 6 months and at 12 months after the HIFU on the ultrasonography.

  A reduction in volume of \> 65% compared to baseline, or a total regression of the fibroadenoma will be taken as effective treatment. The results will be analyzed descriptively

  Baseline, 6 months, 12 months

Secondary Outcomes (7)

• Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up

  1 year

• Lack of palpable lesion

  2 years

• Pain free if pain at baseline (pain related to the fibroadenoma)

  1 year

• Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session

  Day 7, month 6, month 12

• Pain during the HIFU session using a Visual Analog Pain Scale

  0 month

Study Arms (1)

Treatment with high-intensity focused ultrasound

EXPERIMENTAL

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused Ultrasound DEVICE

Treatment with high-intensity focused ultrasound

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 with at least one diagnosed breast fibroadenoma. Diagnosis of fibroadenoma must be based on:
• clinical examination,
• women ≤ 40 years of age: ultrasound image alone; women \> 40 years of age: ultrasound image and mammogram,
• histological confirmation of fibroadenoma of the breast. Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment. Patient must be able to understand the nature and the extent of the study and the procedures required and be willing and able to complete the screening and study procedures. Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.

You may not qualify if:

• Patient who is pregnant or breast-feeding.
• Patient with implant on the treated breast.
• Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Theraclion: collaborator

Study Sites (1)

Department for Women's Health

Tübingen, 72076, Germany

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: January 16, 2017
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 22, 2024

Record last verified: 2015-06

Locations

DE (1)