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ABLATE Registry

ABLATE RegistryDr. V. Suzanne Klimberg, Director of the Breast Program at UAMS, is a pioneer in the use of Radiofrequency Ablation (RFA) in the treatment of breast cancer.

ABLATE (Radiofrequency Ablation After Breast Lumpectomy Added to Extend Intraoperative Margins in the Treatment of Breast Cancer)  is a trial currently enrolling subjects at UAMS.  Excision of the breast cancer by lumpectomy is combined with RFA (eRFA) of the cavity to examine the effectiveness of creating an area where no cancer cells are found once the primary tumor has been removed.

The standard lumpectomy makes an incision in the skin approximately the size of the mass to remove the mass and a rim (safety zone) of normal tissue around it all in one piece.

In our study, after the standard lumpectomy, RFA is used to ablate (heat) this area of tissue around the lumpectomy cavity, which results in the destruction of any cell in the zone left by the lumpectomy.

It is our hope that:

  1. Return visits to the operating room for close or positive margins will be avoided
  2. Less tissue will have to be removed resulting in better cosmetic results

This is a multi-center study, meaning that in addition to UAMS, other centers/surgeons across
the country are enrolling subjects.  A total of 250 subjects will be accrued.

To be eligible you must meet the criteria list below:

Inclusion/Eligibility

  • 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 (cancer involves only one site, in only one breast)
  • 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/Ineligibility

  • 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

If you would like to participate or know more about the study, please contact:

Laura Adkins, MAP, CCRP
Study Coordinator
Regulatory Affairs Officer, Winthrop P. Rockefeller Cancer Institute
Email: lladkins@uams.edu
Phone: (501) 526-6990 x8268
Fax: (501) 526-6191

Click see the stories and sites below for more information:
Breast Cancer Treatment Developed by UAMS Surgeon

Breast Cancer Study Finds Alternative to Radiation Therapy

IMPORTANT DOCUMENTS FOR INSTITUTIONS PARTICIPATING IN THE MULTICENTER REGISTRY:

 ABLATE Registry Protocol ABLATE CRF 01.doc ABLATE CRF 05.doc ABLATE CRF 09.doc
 ABLATE consent form ABLATE CRF 02.doc ABLATE CRF 06.doc ABLATE CRF 10.doc
 ACTIVE ABLATE HIPAA Form ABLATE CRF 03.doc ABLATE CRF 07.doc ABLATE CRF 11.doc
 ABLATE Budget ABLATE CRF 04.doc ABLATE CRF 08.doc ABLATE CRF 12.doc
 EXPECTED FROM SITES