Efficacy of MR-HIFU Ablation of Breast Cancer

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    10
  • sponsor
    UMC Utrecht
Updated on 30 June 2022
carcinoma
invasive breast cancer
breast cancer staging
ductal carcinoma
early-stage breast cancer

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.

Details
Condition Breast Cancer
Treatment Philips Sonalleve MR-HIFU Breast Tumor Therapy System
Clinical Study IdentifierNCT02407613
SponsorUMC Utrecht
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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
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