Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
|ClinicalTrials.gov Identifier: NCT03523299|
Recruitment Status : Withdrawn (Principal investigator wishes to revisit design and start a new study)
First Posted : May 14, 2018
Last Update Posted : August 21, 2019
This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.
Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
|Condition or disease||Intervention/treatment||Phase|
|Invasive Ductal Carcinoma, Breast||Procedure: Cryoablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer|
|Actual Study Start Date :||May 22, 2018|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||August 1, 2019|
Participants in this 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).
Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. 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 mm incision and inserts needle-like cryoprobes into the tumor, commencing 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.
No Intervention: Control
Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).
- Incidence of treatment-emergent adverse events [safety] [ Time Frame: 1 day after cryoablation ]Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
- Immune response [ Time Frame: One week after lumpectomy ]Immunohistochemical analysis of biomarkers in blood and resected tissue
- Cosmetic outcome [ Time Frame: Change from one month to one year after lumpectomy ]Change in appearance based on distortion and volume loss of the breast
- Tumor margin status [effectiveness] [ Time Frame: 7-10 days after lumpectomy ]Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523299
|Principal Investigator:||Cesar Santa-Maria, MD||Johns Hopkins University|