Clinical trial · Interventional
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high-intensity focused ultrasound ablation | Device | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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