NCT00571987

Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer of the Breast

Interventions

Type	Name	Description
DEVICE	AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)	Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

Timeline

• Start date: 2004-09-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2007-12-12
• Last updated: 2015-11-24
• Results posted: 2015-10-06

Locations

1 site across 1 country: United States