Treatment of Breast Fibroadenoma With High Intensity NCT01331954

Updated 06/21/2024

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT01331954
Other study ID #	HIFU/BG/FA/Jan2011
Secondary ID
Status	Active, not recruiting
Phase	N/A
First received
Last updated
Start date	March 2011
Est. completion date	September 2024

Study information
Verified date	April 2024
Source	Theraclion
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	20
Est. completion date	September 2024
Est. primary completion date	September 2024
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years and older
Eligibility	Inclusion Criteria: - One breast fibroadenoma with diagnosis based on: - Clinical examination - Ultrasound image - For women older than 35 years: mammogram with BI-RADS score < 3 - Histologic confirmation by two independent readers - Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound) Exclusion Criteria: - Patient pregnant or lactating - Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion. - History of breast cancer or history of laser or radiation therapy to the target breast - Breast implants - Breast cyst - Fibroadenoma not clearly visible on the ultrasound images (in B mode) - Patient participating in other trials using drugs or devices

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Ultrasonic ablation device
One or two HIFU procedures

Locations
Country	Name	City	State
Bulgaria	University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"	Sofia

Sponsors *(1)*
Lead Sponsor	Collaborator
Theraclion

Country where clinical trial is conducted

Bulgaria,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of breast fibroadenoma volume at ultrasonography		12 months

See also
	Status	Clinical Trial	Phase
	Completed	`NCT03022695` - Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)	N/A
	Completed	`NCT01422629` - High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma	N/A
	Recruiting	`NCT06016790` - Exploring a Breast Cancer Early Screening Model Based on cfDNA
	Completed	`NCT04297007` - Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery	N/A
	Completed	`NCT02488655` - Treatment of Breast Fibroadenoma With FastScan HIFU	N/A
	Terminated	`NCT03742401` - Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)	N/A
	Completed	`NCT04341129` - Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)	Early Phase 1
	Not yet recruiting	`NCT03868475` - Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions	N/A
	Recruiting	`NCT03044054` - Treatment of Breast Fibroadenoma Targeted Tissue With HIFU	N/A
	Completed	`NCT02139683` - Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU	N/A
	Terminated	`NCT00147108` - MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas	Phase 3
	Completed	`NCT03470051` - Case Collection Study in the Evaluation of Doubling Time Rates in Non-Suspicious Breast Masses Using QT Ultrasound Technology
	Completed	`NCT02011919` - Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)	N/A
	Completed	`NCT03715413` - Analgesic Efficacy of Pulsed Radiofrequency in Non-cyclic Mastalgia	Phase 2
	Completed	`NCT06026176` - Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS
	Completed	`NCT02078011` - Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound	N/A