MRI-guided High-Intensity Focused Ultrasound Ablation of Breast Cancer

Phase 2

Completed

Conditions: 10006291
10006232
10006295
breast cancer
malignant breast neoplasm

Registration Number: NL-OMON39336

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Female aged 18 years and over
Able to give informed consent herself
World Health Organization performance score <= 2
Weight < 80 kg
The target breast fits into the cup of the dedicated MR-HIFU breast system
Patients with cT1-2(>= 1.0 cm) invasive breast cancer, confirmed by histopathology. Size of the tumor is determined on mammography or ultrasound

Exclusion Criteria

Patients treated with neo-adjuvant systemic therapy
Contra-indications for MRI scanning according to the hospital guidelines
Contra-indications to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure, defined by GFR < 30mL/min/1.73m2
Macro calcifications around the targeted tumor
Scar tissue or surgical clips in the direct path of the HIFU beam
Pregnant or lactating women
Patients who don*t want to be informed about unexpected findings on MRI

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this feasibility study is treatment accuracy of MR-HIFU in<br /><br>breast cancer patients using a dedicated MR-HIFU breast system.<br /><br>Accuracy of treatment will be assessed by comparing the ablated volumes by HIFU<br /><br>to three parameters related to the success of HIFU treatment. These parameters<br /><br>are 1) MR thermal dose predicted treatment volumes 2) treatment planning<br /><br>volumes and 3) histopathology. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary endpoint of this study is safety of MR-HIFU in breast cancer<br /><br>patients using a dedicated MR-HIFU breast system.<br /><br>To determine the safety, the following endpoints will be recorded: any minor<br /><br>complications or adverse events that result from HIFU treatment. Pain during<br /><br>HIFU treatment will be recorded according to the Numerical Representative Scale<br /><br>(NRS)</p><br>