Efficacy of MR-HIFU Ablation of Breast Cancer

NCT02407613 | Withdrawn

• 1 other identifier: NL46863.041.14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; MR-HIFU; ablation; non-invasive treatment

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Number of patients with adverse events

  Approximately 2 to 3 weeks

Study Arms (1)

MR-HIFU ablation

EXPERIMENTAL

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).

Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System

Interventions

Philips Sonalleve MR-HIFU Breast Tumor Therapy System DEVICE

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.

MR-HIFU ablation

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Manon NG Braat, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

NL (1)