Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Arkansas
With
Angiodynamics, Inc.
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female, 18-100 years old
Not pregnant or breastfeeding
Pre-study radiologic documentation of:
size ≤ 5 cm
unicentric, unilateral
suspicious mass or calcification
BIRADS classification ≥ IV
location of abnormality \> 1 cm from skin
Ductal or Infiltrating Ductal Carcinoma
Grade I-III on final pathology
Good general health
Zubrod Performance Status of 0,1, or 2
No previous chemotherapy
No palpable axillary or supraclavicular lymph nodes
If prior non-breast malignancy, must have \> 5 year disease-free survival
You may not be if
Patient \< 18 y/o or \> 100 y/o
Pregnant or breastfeeding
Male
Breast implants
Multicentric disease or bilateral disease
Lesions \> 5 cm in diameter
Lesions \< 1.0 cm from the skin
Previous prior radiation to the breast
Need for mastectomy
Diffuse microcalcifications (as determined by the Investigator)
