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

Primary Purpose

Breast Cancer, Invasive Ductal

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Philips Sonalleve® MR-HIFU Breast Therapy System

About this trial

This is an interventional treatment trial for Breast Cancer, Invasive Ductal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Kantonsspital Winterthur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-HIFU treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03560102

First Posted

May 14, 2018

Last Updated

September 23, 2021

Sponsor

Kantonsspital Winterthur KSW

1. Study Identification

Unique Protocol Identification Number

NCT03560102

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

recruitment difficulties

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

February 5, 2020 (Actual)

Study Completion Date

February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kantonsspital Winterthur KSW

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Invasive Ductal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR-HIFU treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Philips Sonalleve® MR-HIFU Breast Therapy System

Intervention Description

The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.

Primary Outcome Measure Information:

Title

Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)

Description

Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

Assessment of Treatment Efficacy

Description

Time Frame

Day 14

Other Pre-specified Outcome Measures:

Title

Incidence of Adverse Events [Safety and Tolerability of the Treatment]

Description

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

Time Frame

Day 0, 3, 8

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph A Binkert, MD

Organizational Affiliation

Kantonsspital Winterthur KSW

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kantonsspital Winterthur

City

Winterthur

ZIP/Postal Code

CH-8401

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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