The HIFUB Study (HIFU in Breast Cancer)

Last updated: April 26, 2022
Sponsor: University of Oxford
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT05350059
233756
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in thetrial.
  • Female, aged 18 years or above.
  • Histologically confirmed breast cancer (invasive ductal cancer) by core biopsy, whichis suitable for surgical resection.
  • Participants must have one non-metastatic, clinically palpable, invasive breast cancermeasuring ≤2cm in its largest dimension, which can be visualised using diagnosticultrasound.
  • 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 berequired for imaging and surgery.
  • In the Investigator's opinion, is able and willing to comply with all trialrequirements.

Exclusion

Exclusion Criteria:

  • Female participant who is pregnant.
  • Significant renal or hepatic impairment.
  • An inadequate biopsy determination of oestrogen, progesterone, HER2 receptor status onpre-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 theunderlying 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 presenceof a heart pacemaker, a metallic foreign body (metal sliver) in the eye, or ananeurysm clip in the brain or severe claustrophobia.

Study Design

Total Participants: 15
Study Start date:
May 01, 2022
Estimated Completion Date:
November 01, 2022