Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment Phase
Breast Cancer Device: ExAblate MRgFUS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Study Start Date : June 2005
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Subjects in this arm are treated once with MRgFUS device
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
    • 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

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): NCT02794558


Sponsors and Collaborators
InSightec
Investigators
Layout table for investigator information
Principal Investigator: Hidemi Furasawa, MD Managing Director at Breastopia Namba Hospital
Layout table for additonal information
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02794558    
Other Study ID Numbers: BC004
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by InSightec:
Breast Cancer, MRgFus, Focused Ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases