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Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

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ClinicalTrials.gov Identifier: NCT02139683
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Theraclion

Study Description
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Brief Summary:
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Device: HIFU treatment Not Applicable

Detailed Description:
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
Actual Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: HIFU treatment
HIFU treatment in patient diagnosed with fibroadenoma
 Device: HIFU treatment
HIFU treatment in patients with fibroadenoma
Other Name: Echopulse


Outcome Measures
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Primary Outcome Measures :
  1. Changes in size of fibroadenomata as recorded on ultrasound imaging [ Time Frame: Month 1, Month 3, Month 12 ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Month 1, Month 3, Month 12 ]
  2. Patient recorded outcomes measures [ Time Frame: Month 1, Month 3, Month 12 ]
    Patient questionnaires and VAS scales

  3. Mean treatment time [ Time Frame: Treatment visit date ]
  4. Cost-effectiveness [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >18 years of age
  • Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
  • Visible on ultrasound (Graded U2/U3)
  • Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).

Exclusion Criteria:

  • Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
  • Pregnant or lactating women
  • History of laser or radiation therapy to the targeted breast
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139683


Locations
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United Kingdom
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Theraclion
King's College London
Investigators
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Principal Investigator: Michael Douek, MD King's College London
More Information
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Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT02139683    
Other Study ID Numbers: HIFU-F
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial