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MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer Clinical research trials and MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer  MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
For Condition: stage 3A breast cancer,stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): InSightec-TxSonics ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertNewman, Study Chair, InSightec-TxSonics
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2X 3J4
Canada
Recruiting David Gianfelice 514-891-8000 ext. 35619
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Kathy Brandt 507-284-2804
Additional Information:
Study ID Numbers: CDR0000068417; TXS-G990184,DFCI-99029,MDA-ID-99137,TXS-1999-P-009925/10,NCI-V00-1643
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008437
Other Stage 1 Breast Cancer Studies:
1. Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
2. Nutrition Intervention in Treating Women With Breast Cancer
3. Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
4. Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
5. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
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