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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer, Invasive Ductal
• Intervention / Treatment: Device: Philips Sonalleve® MR-HIFU Breast Therapy System

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
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Winterthur, Switzerland, CH-8401
    • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events [Safety and Tolerability of the Treatment]	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	Day 0, 3, 8

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2020
• Primary Completion (ACTUAL): February 5, 2020
• Study Completion (ACTUAL): February 5, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (ACTUAL): June 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Breast Neoplasms; Carcinoma, Ductal, Breast
• Other Study ID Numbers: 2017-01282 (BASEC); 2017-MD-0021 (OTHER: Swissmedic)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No