Breast Cancer, Invasive DuctalNCT03560102
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
A study testing Philips Sonalleve® MR-HIFU Breast Therapy System in people with Breast Cancer, Invasive Ductal, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection. Single-center, single-arm, non-randomized trial Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Ductal
- What is being tested?
- Philips Sonalleve® MR-HIFU Breast Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2020to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Informed Consent as documented by signature
- World Health Organization (WHO) performance status≤ 2
- Body weight ≤ 80 kg
- Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ).
- Histological type of tumor: invasive ductal carcinoma (IDC)
- Patient is scheduled for surgical resection of tumor at study site
- Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm.
- Target breast fits in the cup of the dedicated MR-HIFU breast system
Who cannot join
- neoadjuvant systemic therapy
- prior radiotherapy in target breast
- contraindications for MRI
- contraindication for application of gadolinium-based contrast agent
- contraindication for procedural sedation analgesia
- macro-calcifications in or around the targeted tumor
Show all 14Show fewer
- scar tissue or surgical clips in the direct path of the ultrasound beams
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
- Previous enrolment into the current study
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: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.
Single-center, single-arm, non-randomized trial
Read the detailed description
The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.
The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.
The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.
The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future
- Conditions
- Breast Cancer, Invasive Ductal
- Being tested
- Philips Sonalleve® MR-HIFU Breast Therapy System
- Medical subject headings
- Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Sonalleve® MR-HIFU Breast Therapy SystemDevice
The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU treatment | Experimental | Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Receives: Device: Philips Sonalleve® MR-HIFU Breast Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)
Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)
Measured: Day 14
Secondary outcomes (1)
Assessment of Treatment Efficacy
Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (>1mm) (histopathological analysis).
Safety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start13 Jan 2020
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer, Invasive DuctalStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph A Binkert, MD, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560102
- Sponsor's protocol ID
- 2017-01282 (BASEC)
- Other IDs
- 2017-MD-0021, 2017
- Status last verified
- Sep 2021
- First submitted
- 14 May 2018
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. 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: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
- ClinicalTrials.gov ID
- NCT03560102
- Acronym / sponsor ID
- 2017-01282 (BASEC)
- Conditions
- Breast Cancer, Invasive Ductal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.
Single-center, single-arm, non-randomized trial
Detailed description
The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.
The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.
The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.
The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future
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 treatment | Experimental | Device: Philips Sonalleve® MR-HIFU Breast Therapy SystemPatients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature
- World Health Organization (WHO) performance status≤ 2
- Body weight ≤ 80 kg
- Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ).
- Histological type of tumor: invasive ductal carcinoma (IDC)
Key exclusion criteria (14 listed)
- neoadjuvant systemic therapy
- prior radiotherapy in target breast
- contraindications for MRI
- contraindication for application of gadolinium-based contrast agent
- contraindication for procedural sedation analgesia
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 Therapy SystemThe breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine. | Device | MR-HIFU treatment |
Primary outcome
Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)
Time frame: Day 14
Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)
1 secondary outcome
Assessment of Treatment Efficacy
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer, Invasive Ductal
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
Not yet recruitingPhase 4
FES PET/MRI for Occult Disease in Lobular Breast Cancer
Lobular Breast Carcinoma
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 1/2
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Colorectal Cancer, Epithelial Ovarian Cancer
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
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.
Christoph A Binkert, MD principal investigator
Kantonsspital Winterthur KSW
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 Therapy System in people with Breast Cancer, Invasive Ductal, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Oct 2021. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method) (time frame: Day 14). 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 22 Oct 2021.