Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560102
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • 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)
  • Accuracy of MRI as method for assessment of qualitative treatment success (correlation with results of the histopathological analysis performed as reference method) [ Time Frame: Day 14 ]
    Qualitative assessment: spatial congruence of ablated tumor tissue and width of margin
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
Assessment of treatment efficacy [ Time Frame: Day 14 ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 15, 2018)
Incidence of adverse events [Safety and tolerability of the Treatment] [ Time Frame: Day 0, 3, 8 ]
Adverse events, general: Patients will be asked to report information about adverse events at each time point of the study. Information about time of onset, duration, resolution, action to be taken assessment of intensity, relationship with study treatment will be collected. Assessment of additional predefined safety parameters: - Skin changes, assessment in physical examination: presence/absence of redness, burn
  • Palpation breast: lump (mobility of lump related to skin: yes/no)
  • Pain, reported by patient
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Official Title  ICMJE 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
Brief 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

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer, Invasive Ductal
Intervention  ICMJE Device: Philips Sonalleve® MR-HIFU Breast Therapy System
The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Study Arms  ICMJE Experimental: MR-HIFU treatment
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
Intervention: Device: Philips Sonalleve® MR-HIFU Breast Therapy System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christoph A Binkert, MD +41 52 266 2602 christoph.binkert@ksw.ch
Contact: Marlene Wegmann Oswald, PhD +41 52 266 23 29 marlene.wegmann@ksw.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03560102
Other Study ID Numbers  ICMJE 2017-01282 (BASEC)
2017-MD-0021 ( Other Identifier: Swissmedic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kantonsspital Winterthur KSW
Study Sponsor  ICMJE Kantonsspital Winterthur KSW
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph A Binkert, MD Kantonsspital Winterthur KSW
PRS Account Kantonsspital Winterthur KSW
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP