NCT05218044

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

Conditions

• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
PROCEDURE	Cryoablation	The cryoprobe tip will be inserted into the breast and directed under ultrasound guidance to the location where the ultrasound visible marker is located. Next, the cryoprobe will be used to freeze a 4 X 3 X 3 cm diameter area of DCIS using two separate 10-minute freeze cycles separated by a single 10-minute thaw cycle. The cryoprobe will remain in place the entire time. After the second freeze, the cryoprobe will be withdrawn from the breast and a bandage will be applied to the skin.

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-02-01
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States