Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Invasive Ductal Carcinoma, Breast Clinical Trial

Official title:

Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03523299
• Other study ID #: SIB16134
• Secondary ID: IRB00077843
• Status: Withdrawn
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;

• Tumor visible by ultrasound at time of treatment;

• Unifocal primary disease;

• Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);

• Tumor depth = 0.5 cm from the skin or nipple-areola complex;

• Planned lumpectomy

Exclusion Criteria:

• Pregnant patients

• Multifocal or metastatic disease

• Planned neoadjuvant chemotherapy or radiation

• Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging

• Known allergy to both lidocaine and benzocaine

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Invasive Ductal Carcinoma, Breast

Intervention

Procedure:
• Cryoablation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events [safety]	Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes	1 day after cryoablation
Primary	Immune response	Immunohistochemical analysis of biomarkers in blood and resected tissue	One week after lumpectomy
Primary	Cosmetic outcome	Change in appearance based on distortion and volume loss of the breast	Change from one month to one year after lumpectomy
Primary	Tumor margin status [effectiveness]	Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required	7-10 days after lumpectomy