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

NCT ID: NCT03523299

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2019-08-01

Brief 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.

Conditions

Invasive Ductal Carcinoma, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation

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).

Group Type: EXPERIMENTAL

Cryoablation

Intervention Type: PROCEDURE

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

cryosurgery; cryotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesar Santa-Maria, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00077843

Identifier Type: OTHER

Identifier Source: secondary_id

SIB16134

Identifier Type: -

Identifier Source: org_study_id