Breast CancerHIFUBNCT05350059
The HIFUB Study (HIFU in Breast Cancer)
A study testing High Intensity Focused Ultrasound (HIFU) to the Breast Cancer in people with Breast Cancer, run by University of Oxford.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- High Intensity Focused Ultrasound (HIFU) to the Breast Cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of High Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer
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
- Being tested
- High Intensity Focused Ultrasound (HIFU) to the Breast Cancer
- Keywords
- breast cancer, high intensity frequency ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused Ultrasound (HIFU) to the Breast CancerDevice
Breast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: High Intensity Focused Ultrasound (HIFU) to the Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 month following intervention
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)
Measured: 1 month following intervention
To evaluate patient acceptance of HIFU treatment
Using 1 to 1 qualitative interviews with participants.
Measured: 1 month following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gurdeep S Mannu, MRCSEd DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350059
- Sponsor's protocol ID
- 233756
- Acronym
- HIFUB
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer
- ClinicalTrials.gov ID
- NCT05350059
- Acronym / sponsor ID
- HIFUB / 233756
- Conditions
- Breast Cancer
- Keywords
- breast cancer, high intensity frequency ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- High Intensity Focused Ultrasound (HIFU) treatment to breast cancer
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Ultrasound (HIFU) treatment to breast cancer | Experimental | Device: High Intensity Focused Ultrasound (HIFU) to the Breast CancerHigh-Intensity Focused Ultrasound (HIFU) in the Treatment of Early Breast Cancer prior to surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused Ultrasound (HIFU) to the Breast CancerBreast cancer will be ablated using high intensity frequency ultrasound prior to breast surgery | Device | High Intensity Focused Ultrasound (HIFU) treatment to breast cancer |
Primary outcome
To evaluate the efficacy of the HIFU treatment in achieving cancer ablation
Time frame: 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.
3 secondary outcomes
To evaluate the sensitivity and specificity of post-HIFU MRI in assessing HIFU efficacy when compared with histological evaluation of the resected specimen
Time frame: 1 month following intervention
Assessment of the safety and toxicity of HIFU ablation
Time frame: 1 month following intervention
To evaluate patient acceptance of HIFU treatment
Time frame: 1 month following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurdeep S Mannu, MRCSEd DPhil principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Ultrasound (HIFU) to the Breast Cancer in people with Breast Cancer, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gurdeep S Mannu, MRCSEd DPhil (+44(0)1865 289452, gurdeep.mannu@ndph.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of the HIFU treatment in achieving cancer ablation (time frame: 1 month following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.