Efficacy of MR-HIFU Ablation of Breast Cancer

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System

• Registration Number: NCT02407613
• Lead Sponsor: UMC Utrecht

Brief Summary

This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-16
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women, aged 18 years and older.
• Able to give informed consent herself.
• World Health Organization (WHO) performance score ≤ 2.
• Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm.
• Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified (NOS) or no special type (NST).
• The target breast fits in the cup of the dedicated MR-HIFU breast system.
• Patient weight is limited to ≤ 90 kg, because of restrictions to the HIFU table top.

Additional inclusion criteria based on DCE-MRI findings:

• The distance of the tumor, including a 5 mm margin around the tumor, from the skin, nipple and pectoral wall is at least 1.0 cm measured on MRI.
• The tumor is located within the reach of the HIFU beam produced by the transducers in the HIFU breast system.

Exclusion Criteria

• Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
• Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore).
• Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR < 30 ml/min/1,73m2).
• Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
• Extensive intraductal components in the lesion determined by biopsy.
• Scar tissue or surgical clips in the HIFU beam path.
• Inability to lie in prone position.
• Pregnancy or lactation.
• Communication barrier with patient.

The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B&R) grading on the tumor biopsy is considered to high:

• N0, Her2neu negative, <35 years, ≤1cm (T1a/b) with B&R grade 1 or 2 on biopsy.
• N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c) with B&R grade 1 or 2 on biopsy.
• N0, Her2neu negative, ER/PR positive > 50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B&R grade 3 on biopsy and if the MammaPrint is not reimbursed by health insurance also for grade 1 on biopsy.
• N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm (T1c) with B&R grade 1 on biopsy.
• N0, Her2neu negative, ER/PR positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c) with B&R grade 1.

The following group of patients will be excluded based on the results of the MammaPrint:

• Only if the MammaPrint is reimbursed by health insurance: N0, Her2neu negative, ER/PR positive, > 50% ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B&R grade 1 and MammaPrint high risk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-HIFU ablation	Philips Sonalleve MR-HIFU Breast Tumor Therapy System	Ten patients undergo MR-HIFU ablation with the Sonalleve MR-HIFU Breast Tumor Therapy System (Profound Medical). According to a treat-and-resect protocol, these patients also undergo standard therapy consisting of breast cancer surgery 1 to 2 weeks after MR-HIFU treatment (+/- radiotherapy).

Primary Outcome Measures

Name	Time	Method
Presence of non-perfused volumes on DCE-MRI	1 week after MR-HIFU ablation	Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.
Amount of ablated tissue at histopathological examination	2-3 weeks (after surgery is performed)	The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Approximately 2 to 3 weeks	Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands