breast fibroadenoma
Conditions
Interventions
Case series:Microwave ablation for breast breast fibroadenoma
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Women aged = 18 years with invasive breast cancer proven by 10-16 G. core needle biopsy of the breast lesion. Core samples are adequate for estimating tumor grade and for receptor analysis; 2. Patient with contrast-enhanced MR imaging confirming a single focal breast lesion less than 2 cm in diameter, which is clearly correlated to the biopsied breast lesion diagnosed to be breast cancer by biological marker or biopsy under similar radiographic condition; 3. Lesion clearly seen on contrast-enhanced MR and in a treatable location (Lesion planned for ablation that is located a minimum distance from unintended structures: dermal under surface, nipple complex and/or ribs, should be 10.0 mm; 4. Patient who is willing to undergo and be scheduled for sentinel lymph node biopsy (SLNB) either prior or post (during their planned breast cancer surgery) to the breast cancer ablation procedure; 5. Patient scheduled and consented to surgical (lumpectomy or mastectomy) resection of the breast cancer 6.Patient who signs an informed consent form for screening, SLNB, ablation, and follow-up visits
Exclusion criteria
Exclusion criteria: 1. Tamoxifen, Aromatase Inhibitors, and Neoadjuvant chemotherapy within 30 days prior to microwave ablation; 2. Prior XRT or ablative therapy to the target breast; 3. Patients currently receiving anticoagulation therapy within the previous 14 days; 4. Lesions difficult to target (2, including but not limited to patients with renal dysfunction due to hepato-renal syndrome or in the perioperative liver transplantation period; 12. Patient with active and ongoing infection at any body site, e.g. urinary tract infection, respiratory tract infection, and other known infections; 13. poor blood glucose control; 14. severe hypertension (diastolic BP >100 on medication or uncontrolled hypertension with systolic BP >160 and/or diastolic BP >90); 15. Patients with unstable cardiac status including: Unstable angina pectoris on medication; Patients with documented myocardial infarction within six months of protocol entry; Congestive heart failure requiring medication; Patients on anti-arrhythmic drugs; 16. Contraindication to MR or Microwave ablation therapy; 17. Patient with history of deep vein thrombosis; 18. with history of pulmonary embolism; 19. Patient with sleep apnea; 20. Patient with airway problems; 21. Patient with severe claustrophobia; 22. Patient with non-MRI compatible implanted metal devices; 23. Patient with difficulty lying prone and still for up to 1 hours (60 minutes) in the MR unit; 24. Patient who cannot fit comfortably in the magnet or patients >250 lbs; 25. Patient with prior reaction to contrast agent; 26. Patient with history of grand mal seizures; 27. Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 and/or who is on dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ablation area; | — |
Countries
China
Contacts
Public ContactLi Kangan
Shanghai General Hospital
Outcome results
None listed