What side effects are associated with this type of intervention?

Common side effects of treatments for breast fibroadenoma that use focused energy or heat, such as High-Intensity Focused Ultrasound (HIFU), include localized pain, skin burns, and tissue damage at the treatment site. Other potential side effects are infection, swelling, and bruising. Rarely, there may be unintended damage to surrounding tissues or organs.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for breast fibroadenoma that utilize High-Intensity Focused Ultrasound (HIFU). HIFU is a non-invasive technique that uses focused ultrasound waves to generate heat and destroy targeted tissue, and it is currently being studied for its efficacy and safety in treating breast fibroadenoma. Other treatments for breast fibroadenoma typically include surgical excision or minimally invasive procedures, but these do not involve the use of focused ultrasound technology.

What other types of research exist?

Promising novel alternatives to HIFU for treating breast fibroadenoma include cryoablation, which uses extreme cold to destroy tissue, and radiofrequency ablation (RFA), which uses heat generated by radio waves. Both methods are minimally invasive and have shown efficacy and safety in clinical studies.

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Ultrasound Therapy

HIFU for Breast Fibroadenoma (HIFU-003 Trial)

N/A

Recruiting

Research Sponsored by Theraclion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 and months 12

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates a non-surgical treatment using strong sound waves to treat benign breast tumors. It targets patients with breast fibroadenoma and works by heating and destroying the unwanted tissue. High-intensity focused ultrasound (HIFU) has been used in the treatment of breast fibroadenomata.

Who is the study for?

This trial is for women over 18 with breast fibroadenoma, a non-cancerous breast lump. Participants must have a confirmed diagnosis, be candidates for surgery, and not be pregnant or nursing. The fibroadenoma should be visible on ultrasound, at least 1 cm in size but no larger than 10 cc in volume, and not contain calcifications or implants.

What is being tested?

The study tests the safety and effectiveness of High-Intensity Focused Ultrasound (HIFU), using ECHOPULSE to treat breast fibroadenomas. It aims to see if this non-invasive treatment can reduce pain and anxiety associated with these lumps without traditional surgery.

What are the potential side effects?

Potential side effects may include discomfort during the procedure, skin redness or bruising where the HIFU was applied, temporary numbness or tingling in the treated area due to nerve irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 and months 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 and months 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and months 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety level assessment

Pain level assessment

Volume assessment

Secondary study objectives

Freedom from additional procedures for fibroadenoma of the breast

Palpability of the breast fibroadenoma

Patient satisfaction

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ECHOPULSEExperimental Treatment1 Intervention

ECHOPULSE HIFU

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ECHOPULSE

2017

N/A

~50

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High-Intensity Focused Ultrasound (HIFU) treats breast fibroadenoma by using focused ultrasound waves to generate heat, which destroys the targeted tissue. This non-invasive approach is significant for patients as it avoids the need for surgical intervention, thereby reducing recovery time and minimizing the risk of complications. Other common treatments for breast fibroadenoma include surgical excision and cryoablation, which also aim to remove or destroy the fibroadenoma tissue but are more invasive compared to HIFU.