RecruitingNot ApplicableNCT07447414

Luminal Breast Cancer Cryoablation

Cryoablation for the Treatment of Luminal Early Breast Cancer


Sponsor

Lucía Graña López

Enrollment

140 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cryoablation with liquid nitrogen (Prosense® system) for people with breast cancer and breast cancer (early breast cancer). The study is currently recruiting participants at 1 location. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECryoablation 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, Lugo, Spain

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NCT07447414


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