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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT02011919
First received: December 10, 2013
Last updated: April 21, 2016
Last verified: April 2016
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Palpability [ Time Frame: Every year during 5 years ] [ Designated as safety issue: Yes ]
    Lack of palpable lesion

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

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

  • Gland vascularisation [ Time Frame: Every year during 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Histological outcome through core needle biopsy after 12 month

  • Energy settings [ Time Frame: Every year during 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Quality and ease of use of breast immobilization

  • Duration of the treatment session [ Time Frame: Every year during 5 years ] [ Designated as safety issue: Yes ]
    Duration of the treatment session (min)

  • Ease of implementation of treatment [ Time Frame: Every year during 5 years ] [ Designated as safety issue: Yes ]
    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
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011919

Locations
Germany
Tubingen University Hospital
Tubingen, Germany
Sponsors and Collaborators
Theraclion
  More Information

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT02011919     History of Changes
Other Study ID Numbers: HIFU / TU / FA 
Study First Received: December 10, 2013
Last Updated: April 21, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on December 02, 2016