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

Sponsor:	InSightec
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008437

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: high-intensity focused ultrasound ablation	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

December 2000

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008437

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Canada, Quebec
CHUM Hopital Saint-Luc
Montreal, Quebec, Canada, H2X 3J4

Sponsors and Collaborators

InSightec

Investigators

Study Chair:

Robert W. Newman

InSightec

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00008437 History of Changes
Other Study ID Numbers:	CDR0000068417, TXS-G990184, DFCI-99029, MDA-ID-99137, TXS-1999-P-009925/10, NCI-V00-1643
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012