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Could freezing replace the scalpel for some breast cancers?

NCT ID NCT02200705

Disease control Sponsor: IceCure Medical Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether freezing a small, low-risk breast tumor (cryoablation) can control the cancer as well as surgical removal. About 200 women with invasive ductal breast cancer tumors 1.5 cm or smaller will receive cryoablation and be followed for 5 years to check for local recurrence and quality of life. The goal is to see if a needle-based freezing procedure can be a less invasive alternative to lumpectomy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryoablation (freezing) device
What this could lead to
If successful, this could offer a non-surgical treatment option for certain small, early-stage breast cancers, potentially reducing recovery time and scarring.
What could go wrong
This is a single-arm study without a surgery comparison group, so it may not prove cryoablation is as effective as lumpectomy. There is a risk of incomplete tumor freezing or later recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

206 people

The number who actually took part.

Started

Oct 2014

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive ductal breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Breast Specialty care/ Presbyterian Hospital

    Albuquerque, New Mexico, 87114, United States

  • BreastLink

    Santa Ana, California, 92705, United States

  • Bridgeport Hospital, Yale Medical School

    Trumbull, Connecticut, 06611, United States

  • CentraState Medical Center

    Freehold, New Jersey, 07728, United States

  • Cincinnati Breast Surgeons Inc.

    Cincinnati, Ohio, 45227, United States

  • Columbia University/ NY Presbyterian hospital

    New York, New York, 10032, United States

  • Complete Breast Care

    Plano, Texas, 75075, United States

  • Comprehensive Breast Care

    Troy, Michigan, 48085, United States

  • Dalton Surgical Group

    Dalton, Georgia, 30720, United States

  • Indiana University

    Indianapolis, Indiana, 46202-5116, United States

  • Ironwood Cancer & Research Centers

    Glendale, Arizona, 85306, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Mount Sinai Beth Israel

    New York, New York, 10011, United States

  • Regional Medical Imaging

    Flint, Michigan, 48507, United States

  • Thomas Jefferson University hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University hospitals cleveland medical center

    Cleveland, Ohio, 44106, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • West Clinic

    Germantown, Tennessee, 38138, United States

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