Status:
ACTIVE_NOT_RECRUITING
Excision Followed by Radiofrequency Ablation for Breast Cancer
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Angiodynamics, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-100 years
Phase:
NA
Brief Summary
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and conse...
Eligibility Criteria
Inclusion
- Patient is a female, ≥ 50 years of age
- The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
- The tumor is unicentric and unilateral
- The tumor is not involving the skin
- Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
- If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
- Patient signs current written informed consent and HIPAA forms
Exclusion
- Patient is under 50 years of age
- Patient is male
- Tumor \> 3 cm in diameter
- Bilateral malignancy
- Clinically positive lymph nodes
- Tumor involving the skin
- Pathology confirms invasive lobular carcinoma
- Breast implants
- Less than 2 years disease-free survival from previous breast cancer
- Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01153035
Start Date
June 1 2010
End Date
June 1 2027
Last Update
November 10 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85704
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Sharp Oncology (Comprehensive Breast Care of San Diego)
San Diego, California, United States, 92123
4
Comprehensive Breast Care of Denver
Denver, Colorado, United States, 80218