Breast CancerNCT02407613
Efficacy of MR-HIFU Ablation of Breast Cancer
A study testing Philips Sonalleve MR-HIFU Breast Tumor Therapy System in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Philips Sonalleve MR-HIFU Breast Tumor Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, aged 18 years and older.
- Able to give informed consent herself.
- World Health Organization (WHO) performance score ≤ 2.
- Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm.
- Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified (NOS) or no special type (NST).
- The target breast fits in the cup of the dedicated MR-HIFU breast system.
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- Patient weight is limited to ≤ 90 kg, because of restrictions to the HIFU table top.
- Additional inclusion criteria based on DCE-MRI findings:
- The distance of the tumor, including a 5 mm margin around the tumor, from the skin, nipple and pectoral wall is at least 1.0 cm measured on MRI.
- The tumor is located within the reach of the HIFU beam produced by the transducers in the HIFU breast system.
Who cannot join
- Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
- Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore).
- Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR < 30 ml/min/1,73m2).
- Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
- Extensive intraductal components in the lesion determined by biopsy.
- Scar tissue or surgical clips in the HIFU beam path.
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- Inability to lie in prone position.
- Pregnancy or lactation.
- Communication barrier with patient.
- The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B\&R) grading on the tumor biopsy is considered to high:
- N0, Her2neu negative, <35 years, ≤1cm (T1a/b) with B\&R grade 1 or 2 on biopsy.
- N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c) with B\&R grade 1 or 2 on biopsy.
- N0, Her2neu negative, ER/PR positive > 50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 3 on biopsy and if the MammaPrint is not reimbursed by health insurance also for grade 1 on biopsy.
- N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm (T1c) with B\&R grade 1 on biopsy.
- N0, Her2neu negative, ER/PR positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c) with B\&R grade 1.
- The following group of patients will be excluded based on the results of the MammaPrint:
- Only if the MammaPrint is reimbursed by health insurance: N0, Her2neu negative, ER/PR positive, > 50% ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 1 and MammaPrint high risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
- Conditions
- Breast Cancer
- Being tested
- Philips Sonalleve MR-HIFU Breast Tumor Therapy System
- Keywords
- breast cancer, MR-HIFU, ablation, non-invasive treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Sonalleve MR-HIFU Breast Tumor Therapy SystemDevice
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety.
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU ablation | Experimental | Ten patients undergo MR-HIFU ablation with the Sonalleve MR-HIFU Breast Tumor Therapy System (Profound Medical). According to a treat-and-resect protocol, these patients also undergo standard therapy consisting of breast cancer surgery 1 to 2 weeks after MR-HIFU treatment (+/- radiotherapy). Receives: Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of ablated tissue at histopathological examination
The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
Measured: 2-3 weeks (after surgery is performed)
Presence of non-perfused volumes on DCE-MRI
Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
Measured: 1 week after MR-HIFU ablation
Secondary outcomes (1)
Number of patients with adverse events
Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.
Measured: Approximately 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2023
- Study completionDec 2023
Why it stopped: Patient recruitment was not feasible.
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 UMC UtrechtThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manon Braat, UMC Utrecht
- Investigators
- Manon NG Braat, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407613
- Sponsor's protocol ID
- NL46863.041.14
- Status last verified
- May 2024
- First submitted
- 16 Jan 2015
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
- ClinicalTrials.gov ID
- NCT02407613
- Acronym / sponsor ID
- NL46863.041.14
- Conditions
- Breast Cancer
- Keywords
- breast cancer, MR-HIFU, ablation, non-invasive treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patient recruitment was not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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.
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-HIFU ablation | Experimental | Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy SystemTen patients undergo MR-HIFU ablation with the Sonalleve MR-HIFU Breast Tumor Therapy System (Profound Medical). According to a treat-and-resect protocol, these patients also undergo standard therapy consisting of breast cancer surgery 1 to 2 weeks after MR-HIFU treatment (+/- radiotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women, aged 18 years and older.
- Able to give informed consent herself.
- World Health Organization (WHO) performance score ≤ 2.
- Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm.
- Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified (NOS) or no special type (NST).
Key exclusion criteria (17 listed)
- Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
- Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore).
- Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR < 30 ml/min/1,73m2).
- Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
- Extensive intraductal components in the lesion determined by biopsy.
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 |
|---|---|---|
| Philips Sonalleve MR-HIFU Breast Tumor Therapy SystemMagnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety. | Device | MR-HIFU ablation |
Primary outcome
Amount of ablated tissue at histopathological examination
Time frame: 2-3 weeks (after surgery is performed)
The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.
Presence of non-perfused volumes on DCE-MRI
Time frame: 1 week after MR-HIFU ablation
Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
1 secondary outcome
Number of patients with adverse events
Time frame: Approximately 2 to 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Manon NG Braat, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips Sonalleve MR-HIFU Breast Tumor Therapy System in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 10 inclusion and 17 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: withdrawn, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of ablated tissue at histopathological examination (time frame: 2-3 weeks (after surgery is performed)). The study lists 2 primary outcomes in all. 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 21 May 2024.