Overview

This trial is active, not recruiting.

Condition cancer of the breast
Treatment angiodynamics (previously rita med,inc) radiofrequency delivery system (consisting of a generator and starburst xl probe)
Phase phase 1/phase 2
Sponsor University of Arkansas
Collaborator Angiodynamics, Inc.
Start date September 2004
End date June 2014
Trial size 107 participants
Trial identifier NCT00571987, UAMS 29143

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
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.

Primary Outcomes

Measure
Margin Status
time frame: Final surgical pathology review

Secondary Outcomes

Measure
Recurrence of breast cancer at prior site of disease
time frame: Until study end (2 years)

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Principal investigator V. Suzanne Klimberg, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Arkansas.