Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2004 |
| End Date: | December 2013 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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