Status:
UNKNOWN
The HIFUB Study (HIFU in Breast Cancer)
Lead Sponsor:
University of Oxford
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 informatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05350059
Start Date
May 1 2022
End Date
November 1 2022
Last Update
April 27 2022
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