Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Completed · Phase 1/Phase 2
Conditions studied: Cancer of the Breast
In brief
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.
Key facts
- Study ID
- NCT00571987
- Run by
- University of Arkansas
- People needed
- 107
- Starts
- 2004-09-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-11-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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)
Where it is running
- University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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