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Efficacy of MR-HIFU Ablation of Breast Cancer

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ClinicalTrials.gov Identifier: NCT02407613
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Manon Braat, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Philips Sonalleve MR-HIFU Breast Tumor Therapy System Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: MR-HIFU ablation
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
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.




Primary Outcome Measures :
  1. Amount of ablated tissue at histopathological examination [ Time Frame: 2-3 weeks (after surgery is performed) ]
    The amount of ablated tissue and residual viable tumor tissue will be assessed in all tumor slices.

  2. Presence of non-perfused volumes on DCE-MRI [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Approximately 2 to 3 weeks ]
    Adverse events will be documented. The (possible) relationship with MR-HIFU ablation will be asessed in all cases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407613


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Manon NG Braat, MD UMC Utrecht

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Responsible Party: Manon Braat, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02407613     History of Changes
Other Study ID Numbers: NL46863.041.14
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by Manon Braat, UMC Utrecht:
breast cancer
MR-HIFU
ablation
non-invasive treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases