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Procedure
Cryoablation for Breast Cancer
N/A
Waitlist Available
Research Sponsored by IceCure Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years for aes and up to 5 years for saes
Awards & highlights
Study Summary
This trial looks at whether cryoablation, a treatment that uses freezing to destroy cancer cells, is effective on its own, without the need for lumpectomy.
Who is the study for?
This trial is for women aged 50 or older with early-stage breast cancer. Eligible participants have a single, small tumor (≤1.5 cm) that's visible on an ultrasound and has certain characteristics: it must be invasive ductal carcinoma, not too aggressive (Nottingham grade 1-2), hormone receptor-positive, HER2 negative, and suitable for cryoablation treatment.Check my eligibility
What is being tested?
The Ice3 Trial is testing the effectiveness of using a technique called cryoablation with the Ice-Sense3TM/ProSenseTM system to treat low-risk small breast cancers without performing lumpectomy surgery. The goal is to see if this approach can prevent the cancer from coming back locally or spreading elsewhere.See study design
What are the potential side effects?
Cryoablation may cause side effects such as pain at the treatment site, bruising, skin numbness or frostbite-like effects due to freezing temperatures used during the procedure. There might also be risks associated with not removing the tumor surgically.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is positive for estrogen and progesterone receptors but negative for HER2.
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I have been diagnosed with invasive ductal breast cancer through a biopsy.
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My tumor is 1.5 cm or smaller in all dimensions.
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I am 50 years old or older.
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My breast cancer is low or intermediate grade.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years for aes and up to 5 years for saes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years for aes and up to 5 years for saes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
local Inbreast Breast Tumor Recurrence (IBTR) rate
Secondary outcome measures
Adverse events
Breast Cancer Survival.
Breast cosmetics satisfaction
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: single arm, open labelExperimental Treatment1 Intervention
Early stage Breast cancers up to 1.5cm
Find a Location
Who is running the clinical trial?
IceCure Medical Ltd.Lead Sponsor
5 Previous Clinical Trials
412 Total Patients Enrolled
1 Trials studying Breast Cancer
234 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is classified as luminal B.My breast cancer is in one spot and not in both breasts.I had breast cancer before, but my doctor is sure my new tumor is a different primary cancer.My cancer is positive for estrogen and progesterone receptors but negative for HER2.My breast cancer has begun to spread beyond the ducts.I have received chemotherapy before or during surgery for breast cancer.I had surgery to remove or biopsy a lump in my breast for cancer diagnosis or treatment.I have been diagnosed with invasive ductal breast cancer through a biopsy.My tumor is 1.5 cm or smaller in all dimensions.My breast cancer is present in multiple areas of the same or both breasts.I am mentally capable of understanding and signing the consent form.I have lobular carcinoma.I am 50 years old or older.The lesion must be able to be seen on a sonogram at the time of treatment.My cancer is either not driven by estrogen and progesterone, or it is HER2 positive.My breast cancer is low or intermediate grade.My breast cancer is aggressive based on its Nottingham score.You have multiple areas of calcifications in your body.My breast size is suitable for a freezing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: single arm, open label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available in this research endeavor?
"The clinical trial in question, first announced on 10/1/2014 and most recently updated on 3/30/2022 is no longer accepting any new candidates. Nevertheless, there are a staggering 2,602 other trials currently recruiting patients from across the globe."
Answered by AI
What is the geographic scope of this experimental venture?
"Enrolment is open at Indiana University in Indianapolis, Karmanos Cancer Institute of Detroit and West Clinic located in Germantown. In addition to these 3 locations, the study seeks candidates from an additional 19 sites across the US."
Answered by AI
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