Study of ExAblate Focused Ultrasound Ablation of Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01620359
First received: June 13, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI.

The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.


Condition Intervention Phase
Breast Cancer
Device: ExAblate MRgFUS
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of ExAblate Focused Ultrasound Ablation of Breast Cancer Under MR Guidance (MRgFUS) and MRI Evaluation of Ablation

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 5 weeks post treatment ] [ Designated as safety issue: Yes ]
    To evaluate the incidence and severity of the ExAblate MRgFUS device-related complications to establish the safety profile of the ExAblate ablation of breast cancer visible on contrast-enhanced MRI with 5-10 mm margins around the primary tumor

  • Histopathological analyses [ Time Frame: 5 weeks post treatment ] [ Designated as safety issue: Yes ]
    To estimate the effectiveness of ExAblate MRgFUS to ablate 100% of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor.


Secondary Outcome Measures:
  • MR imaging [ Time Frame: 5 weeks post treatment ] [ Designated as safety issue: Yes ]
    To estimate the sensitivity of post-ablation MRI in identifying residual disease following ablation.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExAblate Device: ExAblate MRgFUS
100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor

Detailed Description:

In this international, non-randomized, single-arm study, a total of 200 patients with a positive diagnosis of invasive breast cancer with a scheduled surgical resection will be enrolled into the trial. Eligible participants will be evaluated and treated with ExAblate breast ablation prior to their planned definitive surgical treatment. After the 10 to 21 days post ExAblate therapy, study participants will have another contrast-enhanced MR imaging examination. Their planned tumor excision will then be completed no later than 14 days from the contrast-enhanced, post ExAblate procedure MR imaging examination. Additionally, the end points of the study will be compared against the CORE Pathology Lab results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women age 18 years with invasive breast cancer
  2. Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter
  3. Lesion clearly seen on contrast-enhanced MR and in a treatable location
  4. Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy
  5. Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer
  6. Patient with clinical Stage I disease: T1 M0 N0
  7. Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits.

Exclusion Criteria:

  1. Invasive lobular carcinoma;
  2. DCIS without invasive components on core biopsy;
  3. Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to ExAblate.
  4. Prior XRT or ablative therapy to the target breast;
  5. Patients currently receiving anticoagulation therapy within the previous 14 days;
  6. Lesions difficult to target (<1 cm from skin, nipple or the rib cage), as visualized on pre-therapy MRI;
  7. Microcalcifications as the only sign of breast cancer on imaging studies;
  8. Extensive intraductal components (EIC) on core biopsy.
  9. Patients with breast implants;
  10. Patients with prior surgical clips or other markers at the site of the breast tumor;
  11. Patients with severe cerebrovascular disease (multiple CVA or CVA within 6 months);
  12. hemolytic anemia (hematocrit < 30);
  13. Pregnant or lactating, post-partum women;
  14. Patient overall health status of ASA >2
  15. Patient with active and ongoing infection at any body site;
  16. Poor blood glucose control.
  17. Severe hypertension
  18. Patients with unstable cardiac status
  19. Contraindication to MR or ExAblate ablation therapy
  20. Patient with history of deep vein thrombosis
  21. With history of pulmonary embolism;
  22. Patient with sleep apnea;
  23. Patient with airway problems;
  24. Patient with severe claustrophobia;
  25. Patient with non-MRI compatible implanted metal devices;
  26. Patient with difficulty lying prone and still for up to 3 hours (180 minutes) in the MR unit;
  27. Patient who cannot fit comfortably in the magnet or patients >250 lbs;
  28. Patient with prior reaction to contrast agent;
  29. Patient with history of grand mal seizures;
  30. Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or who is on dialysis;
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620359

Contacts
Contact: Heike R Dier info@fus-bottrop.de

Locations
Germany
Marienhospital Recruiting
Bottrop, Germany, 46236
Contact: Heike Rotter-Dier       info@fus-bottrop.de   
Principal Investigator: Jamshid Farahati, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Hans Kolberg, MD FUS BOTTROP
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01620359     History of Changes
Other Study ID Numbers: BC006
Study First Received: June 13, 2012
Last Updated: June 14, 2012
Health Authority: Germany:BfArm
Spain: AEMPS
Rome: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by InSightec:
Breast cancer
Breast tumor
stage 1 disease
T1 M0 N0

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014