Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer

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: NCT00008437
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE January 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE December 2000
Actual Primary Completion Date December 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
Official Title  ICMJE Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer: MR Imaging and Histopathic Correlation, An Assessment or Target Accuracy and Patient Acceptance
Brief Summary

RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue.

PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I, stage II, or stage IIIA breast cancer.

Detailed Description

OBJECTIVES:

  • Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
  • Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure.
  • Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure.
  • Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis.

OUTLINE: This is a pilot study.

Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy.

Patients are followed at 5-10 days post-surgery.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: high-intensity focused ultrasound ablation
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2000
Actual Primary Completion Date December 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer (T1, N0-2, M0)
  • Single focal lesion no greater than 3.5 cm in diameter by MRI
  • No lesions difficult to target, defined as less than 1 cm from skin, nipple, or rib cage
  • No microcalcifications as sole sign of disease
  • No extensive intraductal components on core biopsy, defined as intraductal carcinoma comprising 25% or more of the invasive breast cancer AND intraductal carcinoma in surrounding normal tissue
  • No breast implants
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • At least 5 years

Hematopoietic:

  • No hemolytic anemia (hematocrit less than 30%)

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No heart disease
  • No unstable angina pectoris requiring medication
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring medication
  • No diastolic blood pressure greater than 100 mm Hg while receiving medication to treat hypertension
  • No cerebrovascular accident (CVA) within the past 6 months
  • No multiple CVAs
  • No cardiac pacemakers

Pulmonary:

  • No chronic obstructive pulmonary disease
  • No other lung disease
  • No sleep apnea or airway problems
  • No severe asthma

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No contraindications to MRI (e.g., implanted medical devices)
  • Must be able to lie prone and still for up to 150 minutes
  • Weight no greater than 250 pounds
  • No severe arthritis
  • No severe claustrophobia
  • No grand mal seizures
  • No insulin-dependent diabetes mellitus
  • No prior reaction to gadolinium-based contrast agent
  • Able to communicate sensations during procedure

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 months since prior chemotherapy

Endocrine therapy:

  • Concurrent hormone replacement therapy allowed
  • Concurrent tamoxifen allowed
  • No concurrent steroids

Radiotherapy:

  • No prior external radiotherapy or laser therapy to ipsilateral breast

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent anti-arrhythmic drugs
  • No concurrent immunosuppressive medication
  • No concurrent anticoagulation therapy
  • No concurrent dialysis
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00008437
Other Study ID Numbers  ICMJE CDR0000068417
TXS-G990184
DFCI-99029
MDA-ID-99137
TXS-1999-P-009925/10
NCI-V00-1643
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert W. Newman InSightec
PRS Account InSightec
Verification Date June 2012

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