Efficacy of MR-HIFU Ablation of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02407613
• Other study ID #: NL46863.041.14
• Status: Withdrawn
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2023

Study information

• Verified date: May 2024
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Philips Sonalleve MR-HIFU Breast Tumor Therapy System
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of ablated tissue at histopathological examination	The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.	2-3 weeks (after surgery is performed)
Primary	Presence of non-perfused volumes on DCE-MRI	Efficacy will be assessed by the presence of non-perfused volumes on DCE-MRI. A pre-treatment MRI is used as comparison.	1 week after MR-HIFU ablation
Secondary	Number of patients with adverse events	Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.	Approximately 2 to 3 weeks