Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

June 10, 2026 updated by: IceCure Medical Ltd.

Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Ironwood Cancer & Research Centers
    • California
      • Santa Ana, California, United States, 92705
        • BreastLink
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Bridgeport Hospital, Yale Medical School
    • Georgia
      • Dalton, Georgia, United States, 30720
        • Dalton Surgical Group
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5116
        • Indiana University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Flint, Michigan, United States, 48507
        • Regional Medical Imaging
      • Troy, Michigan, United States, 48085
        • Comprehensive Breast Care
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • CentraState Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87114
        • Breast Specialty care/ Presbyterian Hospital
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10011
        • Mount Sinai Beth Israel
      • New York, New York, United States, 10032
        • Columbia University/ NY Presbyterian hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Cincinnati Breast Surgeons Inc.
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Clinic
    • Texas
      • Plano, Texas, United States, 75075
        • Complete Breast Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Competent to sign informed consent

  2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:

    1. Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
    2. Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
    3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
    4. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
  3. Age>= 50
  4. Breast size adequate for safe cryoablation
  5. Lesion must be sonographically visible at the time of treatment.
  6. History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criteria if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.

Exclusion Criteria:

  1. Presence of lobular carcinoma
  2. Presence of luminal B pathology
  3. Nottingham score of 3 (specially nuclear and mitotic score>2)
  4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
  5. Presence of multifocal and/or multicentric in breast cancer
  6. Presence of multifocal calcifications
  7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
  8. Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
  9. Patient that is not suitable to cryoablation procedure according to the physician opinion
  10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: single arm, open label
Early stage Breast cancers up to 1.5cm
Device: Ice-Sense3TM/ ProSenseTM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
Time Frame: up to 5 years
6 months post cryoabltion, then annually for 5 years
up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breast Cancer Survival.
Time Frame: up to 5 years
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
up to 5 years
Overall Survival
Time Frame: up to 5 years
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
up to 5 years
Complete Primary Tumor Ablation Rate
Time Frame: up to 5 years from procedure date.
Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation.
up to 5 years from procedure date.
Improvement or Maintenance of Subject's Quality of Life
Time Frame: Baseline and 6 months
Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit.
Baseline and 6 months
Breast Cosmetics Satisfaction
Time Frame: Up to 5 years following procedure
Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
Up to 5 years following procedure
Regional Recurrence Rate
Time Frame: up to 5 years following procedure
Regional Invasive breast tumor recurrence rate.
up to 5 years following procedure
Distant Metastases Survival Rate
Time Frame: up to 5 years following procedure
Distant metastases survival rate, including contralateral Breast cancer
up to 5 years following procedure
Disease-free Survival (DFS)
Time Frame: up to 5 years
DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IceCure Medical Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICMBC-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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