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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Theraclion Identifier:
First received: December 10, 2013
Last updated: April 21, 2016
Last verified: April 2016

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

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device

Condition Intervention Phase
Breast Fibroadenoma Device: Echopulse Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Further study details as provided by Theraclion:

Primary Outcome Measures:
  • FA volume changes from baseline [ Time Frame: Every year during 5 years ]

Secondary Outcome Measures:
  • Palpability [ Time Frame: Every year during 5 years ]
    Lack of palpable lesion

  • Pain assessment [ Time Frame: Every year during 5 years ]
    Pain free if pain at baseline (pain related to the FA)

  • Cosmetic result [ Time Frame: Every year during 5 years ]
    Cosmetic result (as judged by investigator)

  • Gland vascularisation [ Time Frame: Every year during 5 years ]
    Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12, year 2, 3, 4 and 5 after the HIFU session

  • Histological outcome [ Time Frame: Every year during 5 years ]
    Histological outcome through core needle biopsy after 12 month

  • Energy settings [ Time Frame: Every year during 5 years ]
    Energy setting to obtain reduction in volume or total regression of the FA at 12 months, 2, 3, 4 and 5 years follow-up

  • Breast immobilization [ Time Frame: Every year during 5 years ]
    Quality and ease of use of breast immobilization

  • Duration of the treatment session [ Time Frame: Every year during 5 years ]
    Duration of the treatment session (min)

  • Ease of implementation of treatment [ Time Frame: Every year during 5 years ]
    Ease of implementation of treatment

Enrollment: 27
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 procédures 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.

Exclusion Criteria:

  • Patient who is pregnant or breast-feeding.
  • Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
  • 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.
  • Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
  • Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02011919

Tubingen University Hospital
Tubingen, Germany
Sponsors and Collaborators
  More Information

Responsible Party: Theraclion Identifier: NCT02011919     History of Changes
Other Study ID Numbers: HIFU / TU / FA
Study First Received: December 10, 2013
Last Updated: April 21, 2016

Additional relevant MeSH terms:
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial processed this record on September 20, 2017