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Title:
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
Protocol Number:
SIB16134
Phase:
Pilot
Physician:
Susan Harvey
Sites:
Sibley Memorial Hospital
Purpose:
This research study is being done to find out whether a freezing procedure known as cryoablation can improve surgical results for women with early invasive breast cancer.The current treatment for a woman who has invasive breast cancer is a surgery called lumpectomy. In this surgery, the tumor is removed along with a surrounding rim of breast tissue. About 20-30% of the time, women who have lumpectomy must have a second surgery because not all of the cancer was removed.The goal is to find out whether cryoablation of a breast tumor before surgery can decrease the number of times that a second surgery has to be performed. We would also like to explore if freezing the tumor in this manner can assist the body’s immune system in recognizing and fighting the cancer.
Eligibility:
-invasive ductal carcinoma, not metastatic-tumor visible on ultrasound-tumor is medium sized and not next to the skin or nipple-not pregnant-no neoadjuvant radiation or chemotherapy
Treatment:
Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 millimeter incision, inserts needle-like cryoprobes into the tumor, and begins a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention).Participants in the control arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care). They will not undergo the cryoablation procedure.Participants in the cryoablation arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).
Population:
Adult
Last Update
03/05/2019 05:03 AM