The HIFUB Study (HIFU in Breast Cancer) (HIFUB)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: High Intensity Focused Ultrasound (HIFU) to the Breast Cancer

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gurdeep S Mannu, MRCSEd DPhil; Phone Number: +44(0)1865 289452; Email: gurdeep.mannu@ndph.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Focused Ultrasound (HIFU) treatment to breast cancer; 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; Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Gurdeep S Mannu, MRCSEd DPhil, University of Oxford

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: breast cancer; high intensity frequency ultrasound
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 233756

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No