Clinical trial NCT03560102: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Official title: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer, Invasive Ductal
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.

Single-center, single-arm, non-randomized trial

Detailed description: The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.

The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.

The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.

The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* World Health Organization (WHO) performance status≤ 2
* Body weight ≤ 80 kg
* Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ).
* Histological type of tumor: invasive ductal carcinoma (IDC)
* Patient is scheduled for surgical resection of tumor at study site
* Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm.
* Target breast fits in the cup of the dedicated MR-HIFU breast system

Exclusion Criteria:

* neoadjuvant systemic therapy
* prior radiotherapy in target breast
* contraindications for MRI
* contraindication for application of gadolinium-based contrast agent
* contraindication for procedural sedation analgesia
* macro-calcifications in or around the targeted tumor
* scar tissue or surgical clips in the direct path of the ultrasound beams
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study

Primary outcomes:
measure: Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)
timeFrame: Day 14
Secondary outcomes:
measure: Assessment of Treatment Efficacy
timeFrame: Day 14
Other outcomes:
measure: Incidence of Adverse Events [Safety and Tolerability of the Treatment]
timeFrame: Day 0, 3, 8
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Christoph A Binkert, MD
role: PRINCIPAL_INVESTIGATOR
References: