The HIFUB Study (HIFU in Breast Cancer)

Study Overview
=================
Brief Summary
-----------------
High Intensity Focused Ultrasound (HIFU) is a new method of treating solid tumours by thermally ablating them. It has been used in a number of different types of cancers but there is little information on its use in invasive breast cancer (IBC). The investigators aim to assess the efficacy and safety of HIFU in the treatment of IBC. In this study, fifteen otherwise healthy women diagnosed with small, early stage IBC will be treated with HIFU prior to conventional surgical treatment. The effects of HIFU on the resected tumour will be analysed pathologically and correlated with radiological findings. Immune response and participant experience will also be evaluated

Official Title
-----------------
Study of High Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: High Intensity Focused Ultrasound (HIFU) to the Breast Cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the trial. Female, aged 18 years or above. Histologically confirmed breast cancer (invasive ductal cancer) by core biopsy, which is suitable for surgical resection. Participants must have one non-metastatic, clinically palpable, invasive breast cancer measuring ≤2cm in its largest dimension, which can be visualised using diagnostic ultrasound. All participants must have an adequate biopsy determination of oestrogen, progesterone, HER2 receptor status on pre-operative biopsy. Adequate ECG, haematological, renal and hepatic function, as indicated, as would be required for imaging and surgery. In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: Female participant who is pregnant. Significant renal or hepatic impairment. An inadequate biopsy determination of oestrogen, progesterone, HER2 receptor status on pre-operative biopsy. Unable to visualize lesion or tumour boundaries clearly on ultrasound. Subjects with tumours lying less than 5mm to overlying skin or less than 5mm to the underlying muscle on the diagnostic scan. Any uncontrolled illness or any other medical problem that would preclude surgery. The presence of any contraindication for magnetic resonance imaging, e.g. the presence of a heart pacemaker, a metallic foreign body (metal sliver) in the eye, or an aneurysm clip in the brain or severe claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Focused Ultrasound (HIFU) treatment to breast cancer<br>High-Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer prior to surgical resection | Device: High Intensity Focused Ultrasound (HIFU) to the Breast Cancer<br>* Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of the HIFU treatment in achieving cancer ablation | Volume of tumour ablation on histological examination of the surgically excised specimen expressed as a percentage of pretreatment tumour volume on MRI scan. | 1 month following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the sensitivity and specificity of post-HIFU MRI in assessing HIFU efficacy when compared with histological evaluation of the resected specimen | Volume of tumour ablation on histological examination of the surgically excised specimen and volume of tumour ablation on post-treatment MRI expressed as a percentages of pretreatment tumour volume on MRI scan. | 1 month following intervention | 
| Assessment of the safety and toxicity of HIFU ablation | Using the Common Toxicity Criteria for Adverse Events (CTCAC) Grading Guideline (which scores any occurring adverse events with grades between 1 to 5, where higher grades indicate worse outcomes) | 1 month following intervention | 
| To evaluate patient acceptance of HIFU treatment | Using 1 to 1 qualitative interviews with participants. | 1 month following intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, high intensity frequency ultrasound