RecruitingNot ApplicableNCT05505643

Cryoablation vs Lumpectomy in T1 Breast Cancers

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in


Sponsor

Washington University School of Medicine

Enrollment

120 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for small breast cancers: cryoablation (freezing the tumor to destroy it without surgery) versus lumpectomy (traditional surgical removal). The goal is to see if freezing the tumor is just as effective as cutting it out. **You may be eligible if...** - You are at least 50 years old - You have been diagnosed with a small invasive ductal breast cancer (2 cm or smaller, ER-negative and HER2-negative, grade 1 or 2) - Your cancer has not spread to lymph nodes or other organs (T1N0M0) - Any pre-cancerous component (DCIS) makes up less than 25% of the tumor - You are willing to have either cryoablation or lumpectomy **You may NOT be eligible if...** - Your tumor is larger than 2 cm - Your cancer has spread to lymph nodes - Your tumor has a large pre-cancerous component (more than 25%) - You have inflammatory or multi-focal breast cancer - You have a pacemaker or implanted device that would prevent MRI Talk to your doctor to see if this trial is right for you.

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

DEVICEEndocare SlimLine Cryoprobe

The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures.

PROCEDURELumpectomy

Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05505643


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