Treatment of Breast Fibroadenoma With FastScan HIFU

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT02488655
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: Theraclion
• Public title: Treatment of Breast Fibroadenoma With FastScan HIFU
• Scientific title: Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)
• Date of first enrolment: June 2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02488655
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Bulgaria

Contacts

• Name: Roussanka Kovatcheva, Prof.
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female patients 18 years or older with one diagnosed breast fibroadenoma.

- Diagnosis of fibroadenoma must be based on :

- clinical examination,

- ultrasound image alone for patients under 35 years old. For women older than 35
years, a mammogram will be performed in addition to ultrasound. The BI-RADS
(Breast Imaging, Reporting and Data System) score of this mammogram must be less
than 3.

- histologic confirmation after core needle biopsy by two independent readers
(biopsy must be performed at least two weeks before therapy unless a microbiopsy
has been already done less than 3 months before inclusion visit and
histopathology slices are available).

- The requirements for the distance from the skin and the following regions of the
fibroadenoma are:

- = 23 mm from the posterior border of the fibroadenoma

- = 5 mm from the anterior border of the fibroadenoma

- = 11mm from the focal point of the HIFU treatment. These criteria shall be
evaluated immediately prior to treatment once breast is immobilized and
potentially compressed

- The rib cage should not be in the prefocal ultrasound path or behind the target
fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall
only be reached in treatment conditions, once breast is immobilized and potentially
compressed.

- Patient's fibroadenoma is 1 cm or greater at its largest dimension

- Fibroadenoma is palpable

- Patient has signed a written informed consent.

Exclusion Criteria:

- Patient who is pregnant or lactating.

- Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications
within the lesion.

- Patient with history of breast cancer or history

- Patient with history of laser or radiation therapy to the target breast

- Patient with breast implants in the target breast

- Patient with a breast cyst

- Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the
inclusion visit

- Patient participating in other trials using drugs or devices.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Fibroadenoma

Intervention(s)

Device: Echopulse

Primary Outcome(s)

Number of participants with adverse events [Time Frame: 3 days post treatment]

Patient satisfaction questionnaire [Time Frame: 6 months post treatment]

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days [Time Frame: 3 days post treatment]

Number of participants with adverse events [Time Frame: 1 day post treatment]

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days [Time Frame: 7 days post treatment]

Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day [Time Frame: 1 day post treatment]

Change from Baseline volume of the fibroadenoma at 6 months [Time Frame: 6 months post treament]

Number of participants with adverse events [Time Frame: 7 days post treatment]

Secondary Outcome(s)

Change from Baseline gland vascularization at 6 months [Time Frame: 6 months post treatment]

Investigator rated evaluation of the device [Time Frame: Post treatment Day 0]

Change from Baseline gland vascularization at 3 months [Time Frame: 3 months post treatment]

Number of participants with absence of palpable lesion [Time Frame: 3 months post treatment]

Number of participants with absence of palpable lesion [Time Frame: 6 months post treatment]

Patient Cosmetic evaluation as measured by questionnaire [Time Frame: 6 months post treatment]

Secondary ID(s)

HIFU/BG/FA/FS/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors