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

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ClinicalTrials.gov Identifier: NCT03560102
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

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


Condition or disease Intervention/treatment Phase
Breast Cancer, Invasive Ductal Device: Philips Sonalleve® MR-HIFU Breast Therapy System Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. 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



Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560102


Contacts
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

Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
Principal Investigator: Christoph A Binkert, MD Kantonsspital Winterthur KSW

Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03560102     History of Changes
Other Study ID Numbers: 2017-01282 (BASEC)
2017-MD-0021 ( Other Identifier: Swissmedic )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary