Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

Status Terminated

Clinical Trial Summary

This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

Clinical Trial Description

Fibroadenomas are well-circumscribed benign tumors, easily distinguishable from adjacent normal breast tissue on ultrasound images.

The goal of this protocol is to compare HIFU and surgery in terms of cost, safety, and clinical effectiveness for the treatment of nonmalignant breast tumors.

Fibroadenomas appear to be an ideal target for evaluation of ultrasound guided HIFU treatment. However, not all the FA are suitable for surgical treatment and in many cases surveillance associated or not with hormonal medication may be sufficient for limiting the symptoms at the degree compatible with a good quality of life for the patients. In addition, from the fraction of the patients for which ablation is a genuine medical need due to the severity of the pathology (size, symptoms, disturbed daily activity with possible psychological impact), only a part of them are suitable for undergoing the HIFU treatment.

Therefore, all the patients to be included in this study have an initial indication of surgical resection of the adenoma. Unlike the patients presenting FA and suitable for medication and surveillance, the cases for which surgery is an indication are symptomatic (significant pain, discomfort, anxiety) and/or are presenting a growth observed during their surveillance with ultrasound examination. In addition, all the eligible patients will have to comply with the technical limitations of the HIFU method in terms of lump size, subcutaneous depth, presence of calcifications and other contraindications like presence of breast implants or under areolar location. Knowing that after the age of 45 years the lumps are in many institutions reserved exclusively for surgery in order to eliminate all suspicion of malignancy, the upper age limit is fixed at 45. Further limitations as established by the American Society of Breast Surgeons for potential candidates of percutaneous excision will be added as inclusion criteria for all patients (the lesion must be sonographically visible, the diagnosis of FA must be confirmed histologically, lesions should be less than 4cm in largest diameter). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03742401
Study type	Interventional
Source	Theraclion
Contact
Status	Terminated
Phase	N/A
Start date	June 11, 2018
Completion date	April 30, 2019

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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
Active, not recruiting	`NCT01331954` - Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)	N/A
Completed	`NCT02488655` - Treatment of Breast Fibroadenoma With FastScan 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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms