search
Back to results

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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Focused Ultrasound (HIFU) to the Breast Cancer
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, high intensity frequency ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    High Intensity Focused Ultrasound (HIFU) treatment to breast cancer

    Arm Description

    High-Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer prior to surgical resection

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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)
    To evaluate patient acceptance of HIFU treatment
    Using 1 to 1 qualitative interviews with participants.

    Full Information

    First Posted
    March 1, 2022
    Last Updated
    April 26, 2022
    Sponsor
    University of Oxford
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05350059
    Brief Title
    The HIFUB Study (HIFU in Breast Cancer)
    Acronym
    HIFUB
    Official Title
    Study of High Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    November 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oxford

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast cancer, high intensity frequency ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
    Arm Type
    Experimental
    Arm Description
    High-Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer prior to surgical resection
    Intervention Type
    Device
    Intervention Name(s)
    High Intensity Focused Ultrasound (HIFU) to the Breast Cancer
    Intervention Description
    Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery
    Primary Outcome Measure Information:
    Title
    To evaluate the efficacy of the HIFU treatment in achieving cancer ablation
    Description
    Volume of tumour ablation on histological examination of the surgically excised specimen expressed as a percentage of pretreatment tumour volume on MRI scan.
    Time Frame
    1 month following intervention
    Secondary Outcome Measure Information:
    Title
    To evaluate the sensitivity and specificity of post-HIFU MRI in assessing HIFU efficacy when compared with histological evaluation of the resected specimen
    Description
    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.
    Time Frame
    1 month following intervention
    Title
    Assessment of the safety and toxicity of HIFU ablation
    Description
    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)
    Time Frame
    1 month following intervention
    Title
    To evaluate patient acceptance of HIFU treatment
    Description
    Using 1 to 1 qualitative interviews with participants.
    Time Frame
    1 month following intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gurdeep S Mannu, MRCSEd DPhil
    Phone
    +44(0)1865 289452
    Email
    gurdeep.mannu@ndph.ox.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gurdeep S Mannu, MRCSEd DPhil
    Organizational Affiliation
    University of Oxford
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The HIFUB Study (HIFU in Breast Cancer)

    We'll reach out to this number within 24 hrs