The HIFUB Study (HIFU in Breast Cancer)

NCT05350059 | Unknown DMC

• 1 other identifier: 233756
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Keywords

breast cancer; high intensity frequency ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Assessment of the safety and toxicity of HIFU ablation

  1 month following intervention

• To evaluate patient acceptance of HIFU treatment

  1 month following intervention

Study Arms (1)

High Intensity Focused Ultrasound (HIFU) treatment to breast cancer

EXPERIMENTAL

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

Interventions

High Intensity Focused Ultrasound (HIFU) to the Breast Cancer DEVICE

Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery

High Intensity Focused Ultrasound (HIFU) treatment to breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gurdeep S Mannu, MRCSEd DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gurdeep S Mannu, MRCSEd DPhil

CONTACT

+44(0)1865 289452; gurdeep.mannu@ndph.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: High Intensity Focused Ultrasound (HIFU) treatment to breast cancer

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 27, 2022
• Study Start: May 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04