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Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794558
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date July 1, 2019
Study Start Date  ICMJE June 2005
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2016)
Post treatment local recurrence [ Time Frame: 5 years ]
new appearance of a malignant tissue of the same type as the treated primary breast lesion, in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Official Title  ICMJE A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: ExAblate MRgFUS

MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed.

Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment.

Other Name: Focused Ultrasound
Study Arms  ICMJE Experimental: Treatment Arm
Subjects in this arm are treated once with MRgFUS device
Intervention: Device: ExAblate MRgFUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2016)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
    • Severe hypertension (diastolic BP > 100 on medication).
    • Patients with cardiac pacemakers.
  • Immunosuppressed patients, e.g., patients receiving steroids or other immunosuppressive medication, insulin-dependent diabetes mellitus, collagen vascular disease.
  • Patients receiving chemotherapy
  • Patients with history of grand mal seizures, severe cerebrovascular disease (multiple CVA or CVA within 6 months), hemolytic anemia (hematocrit < 30), or patients on dialysis.
  • Patients currently receiving anticoagulation therapy.
  • Large patients who cannot fit comfortably in the magnet, or patients > 100Kg.
  • Lesions difficult to target (<1 cm from skin, nipple-areola complex or the ribcage), as visualized on pre-therapy MRI.
  • Microcalcifications as the only sign of breast cancer on imaging studies.
  • Patients with breast implants.
  • Prior reaction to gadolinium-based contrast agent
  • Prior radiation to the breast, which is about to be treated.
  • Evidence of tumor at any location other then the targeted lesion.
  • Histological type of invasive micropapillary carcinoma because of cancer displacement by the needle
  • Mucinous carcinoma which was diagnosed by core needle biopsy because of needle cancer displacement
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794558
Other Study ID Numbers  ICMJE BC004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hidemi Furasawa, MD Managing Director at Breastopia Namba Hospital
PRS Account InSightec
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP