Breast Cancer
Conditions
Keywords
breast cancer, high intensity frequency ultrasound
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
Interventions
DEVICEHigh Intensity Focused Ultrasound (HIFU) to the Breast Cancer
Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery
Sponsors
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of the HIFU treatment in achieving cancer ablation | 1 month following intervention | Volume of tumour ablation on histological examination of the surgically excised specimen expressed as a percentage of pretreatment tumour volume on MRI scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the sensitivity and specificity of post-HIFU MRI in assessing HIFU efficacy when compared with histological evaluation of the resected specimen | 1 month following intervention | 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. |
| Assessment of the safety and toxicity of HIFU ablation | 1 month following intervention | 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) |
| To evaluate patient acceptance of HIFU treatment | 1 month following intervention | Using 1 to 1 qualitative interviews with participants. |
Contacts
Primary ContactGurdeep S Mannu, MRCSEd DPhil
Outcome results
None listed