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NOT YET RECRUITING
NCT07447414
NA

Luminal Breast Cancer Cryoablation

Sponsor: Lucía Graña López

View on ClinicalTrials.gov

Summary

LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women

Official title: Cryoablation for the Treatment of Luminal Early Breast Cancer

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-03

Completion Date

2028-12

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DEVICE

Cryoablation with liquid nitrogen (Prosense® system)

The appropriate cryoprobe (10G or 13G) will be selected depending on the size of the tumor. After injecting local anesthesia, the cryoprobe will be inserted along the longest diameter of the lesion. The tip of the needle will be advanced so that the freezing center is located in the middle of the tumor. Two freezing cycles will be performed, separated by a thawing cycle, all three of the same duration, which depends on the size of the tumor. The goal is a freezing volume with a lethal zone covering the lesion and a safety margin of at least 1 cm. Ultrasound allows real-time monitoring of the expansion of the ice ball during cryoablation. To avoid burning the skin, we will inject warm sterile saline solution when the distance between the ice and the skin surface is less than 0.5 cm

Locations (1)

Hospital Universitario Lucus Augusti

Lugo, Spain