The HIFUB Study (HIFU in Breast Cancer)

• Sponsor: University of Oxford (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05350059
• Collaborator: (none)
• Enrollment: 15
• Arm: 1
• Anticipated Duration (Months): 6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: High Intensity Focused Ultrasound (HIFU) to the Breast Cancer	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: High Intensity Focused Ultrasound (HIFU) treatment to breast cancerHigh Intensity Focused Ultrasound (HIFU) treatment to breast cancer
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of High Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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)

3. To evaluate patient acceptance of HIFU treatment [1 month following intervention]

   Using 1 to 1 qualitative interviews with participants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Oxford

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT05350059
• Other Study ID Numbers: 233756
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Oxford: breast cancer; high intensity frequency ultrasound
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 27, 2022