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

NCT03560102 | Terminated Results

• 2 other identifiers: 2017-01282 (BASEC)2017-MD-0021
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer, Invasive Ductal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Treatment Efficacy

  Day 14

Other Outcomes (1)

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

  Day 0, 3, 8

Study Arms (1)

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

Device: Philips Sonalleve® MR-HIFU Breast Therapy System

Interventions

Philips Sonalleve® MR-HIFU Breast Therapy System DEVICE

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

MR-HIFU treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, CH-8401, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Christoph A Binkert (Sponsor-Investigator)
• Organization: Kantonsspital Winterthur

christoph.binkert@ksw.ch

+41 52 266 2602

Study Officials

• Christoph A Binkert, MD

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 18, 2018
• Study Start: January 13, 2020
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-09

Locations

CH (1)