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Clinical Trials/NCT01422629
NCT01422629
Completed
Not Applicable

High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

Theraclion2 sites in 1 country24 target enrollmentOctober 2011
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ConditionsBreast Fibroadenoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Fibroadenoma
Sponsor
Theraclion
Enrollment
24
Locations
2
Primary Endpoint
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Theraclion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
  • •Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)

Exclusion Criteria

  • •Patient pregnant or lactating
  • •Microcalcifications within the lesion at the mammogram.
  • •History of breast cancer or history of laser or radiation therapy to the target breast
  • •Breast implant in the target breast.
  • •Fibroadenoma not clearly visible on the ultrasound images (in B mode)
  • •Patient participating in other trials using drugs or devices

Outcomes

Primary Outcomes

HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma

Time Frame: 6 months after HIFU treatment

Secondary Outcomes

  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale.(at treatment)
  • Percentage of patients with Adverse events(at 12 months follow-up)
  • Volume reduction of the fibroadenoma(12 months after HIFU treatment)

Study Sites (2)

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