A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- InSightec
- Enrollment
- 100
- Primary Endpoint
- Incidence and severity of Adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Detailed Description
Study specific aim is to Coagulate the tissue volume of a proven breast cancer with MRgFUS and Collect post treatment follow-up clinical and radiological data for a period of 5 years following MRgFUS for breast cancer. Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period. Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment. Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women age ≥ 18 years with - breast cancer proven by 14-20 G. core needle biopsy of the breast lesion.
- •No evidence of cancer at the sentinel/ Axillary node
- •Women in whom breast MR imaging identifies a single focal well-demarcated breast lesion less than or equal to 1.5 cm in diameter with stage T1, N0, M0 disease.
- •Patient received neoadjuvant care for 4 weeks such as: Hormone replacement therapy or Tamoxifen is permissible where the tumor is less than or equal to 1.5 before neoadjuvant therapy
- •Able and willing to give consent and able to attend all study visits.
- •Able to communicate sensations during the MRgFUS procedure.
- •Life expectancy of 5 years or more.
Exclusion Criteria
- •Breast cancer which was diagnosed by incisional / excisional biopsy
- •Contraindication to MRI (non-MRI compatible implanted metal devices).
- •Pregnant or lactating post partum women.
- •Prior XRT or laser or cryo-therapy to the target breast.
- •Difficulty lying prone and still for up to 210 minutes in the MR unit, e.g., COPD, heart disease, lung disease, sleep apnea or airway problems, severe asthma, severe arthritis, severe claustrophobia.
- •Patients with unstable cardiac status including:
- •Unstable angina pectoris on medication.
- •Patients with documented myocardial infarction within six months of protocol entry.
- •Congestive heart failure requiring medication.
- •Patients on anti-arrhythmic drugs.
Outcomes
Primary Outcomes
Incidence and severity of Adverse events
Time Frame: 5 years
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications
Secondary Outcomes
- Post treatment local recurrence(5 years)