NCT00008437

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2000

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

Same day

First QC Date

January 6, 2001

Last Update Submit

June 29, 2012

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage IIIA breast cancer

Interventions

high-intensity focused ultrasound ablationDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CHUM Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Robert W. Newman

    InSightec

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Primary Completion

December 1, 2000

Study Completion

December 1, 2000

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

US(1)CA(1)