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Completed

NCT Number: NCT01422629

High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

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.

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Key information

Conditions

Breast Fibroadenoma Fibroadenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic ablation device

Device

High Intensity focused ultrasound treatment

Other names: TH-One

Primary outcomes

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

    Time frame: 6 months after HIFU treatment

Secondary outcomes

  1. Volume reduction of the fibroadenoma

    Time frame: 12 months after HIFU treatment

    reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery

  2. - Pain score during the HIFU treatment evaluated by the Visual Analog Scale.

    Time frame: at treatment

  3. Percentage of patients with Adverse events

    Time frame: at 12 months follow-up

Sponsors and collaborators

Lead sponsor

Theraclion

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2011
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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