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To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, open label | Other | Early stage Breast cancers up to 1.5cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice-Sense3TM/ ProSenseTM | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Local Inbreast Breast Tumor Recurrence (IBTR) Rate | 6 months post cryoabltion, then annually for 5 years | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Primary Tumor Ablation Rate | 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 |
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Inclusion Criteria:
Competent to sign informed consent
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Age>= 50
Breast size adequate for safe cryoablation
Lesion must be sonographically visible at the time of treatment.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Glendale | Arizona | 85306 | United States | ||
| BreastLink |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39909175 | Derived | Jean J, Jochelson MS, Moo TA, Solomon SB, Bryce Y. Breast Cancer Recurrence after Cryoablation in Patients Who Are Poor Surgical Candidates or Who Refuse Surgery. J Vasc Interv Radiol. 2025 Jun;36(6):971-978. doi: 10.1016/j.jvir.2025.01.048. Epub 2025 Feb 3. |
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A total of 212 Subjects were screened for enrollment in the study; 3 were screen failures, and 3 subjects withdrew consent before the procedure; 206 were enrolled and treated. Based on the DSMB recommendation, 12 subjects were excluded from the study after completing the cryoablation procedure. Nine (9) were due to deviation from inclusion criteria, and three (3) were due to incomplete treatment, resulting in the per-protocol study population of 194 subjects.
The study was conducted at 19 sites in the USA. All study investigators had related experience in low-risk breast cancer treatment, imaging, and pathology assessments and were trained to perform the cryoablation procedure. The recruitment period lasted from October 2014 to February 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm, Open Label | Subjects with early-stage (up to 1.5 cm), low-risk breast cancer who met the eligibility criteria outlined in the study protocol were enrolled and underwent cryoablation using the IceCure Medical Ice-Sense3™/ProSense™ system. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2021 |
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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 | Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation. | Up to 5 years following procedure |
| Regional Recurrence Rate | Regional Invasive breast tumor recurrence rate. | up to 5 years following procedure |
| Distant Metastases Survival Rate | Distant metastases survival rate, including contralateral Breast cancer | up to 5 years following procedure |
| Disease-free Survival (DFS) | 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 |
| Overall Survival | 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 |
| Breast Cancer Survival. | 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 |
| Santa Ana |
| California |
| 92705 |
| United States |
| Bridgeport Hospital, Yale Medical School | Trumbull | Connecticut | 06611 | United States |
| Dalton Surgical Group | Dalton | Georgia | 30720 | United States |
| Indiana University | Indianapolis | Indiana | 46202-5116 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Regional Medical Imaging | Flint | Michigan | 48507 | United States |
| Comprehensive Breast Care | Troy | Michigan | 48085 | United States |
| CentraState Medical Center | Freehold | New Jersey | 07728 | United States |
| Breast Specialty care/ Presbyterian Hospital | Albuquerque | New Mexico | 87114 | United States |
| Mount Sinai Beth Israel | New York | New York | 10011 | United States |
| Columbia University/ NY Presbyterian hospital | New York | New York | 10032 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Cincinnati Breast Surgeons Inc. | Cincinnati | Ohio | 45227 | United States |
| University hospitals cleveland medical center | Cleveland | Ohio | 44106 | United States |
| Thomas Jefferson University hospital | Philadelphia | Pennsylvania | 19107 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Complete Breast Care | Plano | Texas | 75075 | United States |
| Per-protocol study population |
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| COMPLETED |
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| NOT COMPLETED |
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The primary analysis set includes 194 subjects (following the DSMB exclusion of 12 subjects).
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm, Open Label | Subjects with early-stage (up to 1.5 cm), low-risk breast cancer who met the eligibility criteria outlined in the study protocol were enrolled and underwent cryoablation using the IceCure Medical Ice-Sense3™/ProSense™ system. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type of Tumor | Subtype of breast cancer based on the cancer's molecular characteristics | Count of Participants | Participants |
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| ER (Estrogen Receptor) | Lab assessment (IHC) of the percentage of estrogen receptors on breast cancer cells. ER-positive is defined when ≥1% of tumor cell nuclei stain positive. | Count of Participants | Participants |
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| PR (Progesterone Receptor) | Lab assessment (IHC) of the percentage of progesterone receptors on breast cancer cells. PR-positive is defined when ≥1% of tumor cell nuclei stain positive. | Count of Participants | Participants |
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| Her2neu | HER2 status is assessed by IHC to measure the amount of HER2 protein on the surface of breast cancer cells. HER2-negative is no staining or incomplete staining in >10% of cells. HER2-positive is strong complete staining in >10% of cells. HER2-negative breast cancer is a less aggressive form of cancer than HER2-positive cancers. | Count of Participants | Participants |
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| Nottingham Grade (1-3) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Inbreast Breast Tumor Recurrence (IBTR) Rate | 6 months post cryoabltion, then annually for 5 years | Posted | Number | 95% Confidence Interval | Percentage of participants with IBTR | up to 5 years |
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| ||||||||||||||||||||||||||
| Secondary | Complete Primary Tumor Ablation Rate | Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation. | Posted | Number | Percentage of participants | up to 5 years from procedure date. |
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| Secondary | Improvement or Maintenance of Subject's Quality of Life | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 6 months |
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| Secondary | Breast Cosmetics Satisfaction | Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation. | Posted | Number | Percentage of participants | Up to 5 years following procedure |
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| Secondary | Regional Recurrence Rate | Regional Invasive breast tumor recurrence rate. | Posted | Number | Percentage of participants | up to 5 years following procedure |
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| Secondary | Distant Metastases Survival Rate | Distant metastases survival rate, including contralateral Breast cancer | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 5 years following procedure |
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| Secondary | Disease-free Survival (DFS) | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 5 years |
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| Secondary | Overall Survival | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 5 years |
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| Secondary | Breast Cancer Survival. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | up to 5 years |
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Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm, Open Label | Subjects with early-stage (up to 1.5 cm), low-risk breast cancer who met the eligibility criteria outlined in the study protocol were enrolled and underwent cryoablation using the IceCure Medical Ice-Sense3™/ProSense™ system. | 21 | 206 | 0 | 206 | 97 | 206 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE v.4.03 | Non-systematic Assessment | 39 events of local pain. 1 non-cardiac chest pain and 1 pain in extremity |
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| Localized Edema | General disorders | CTCAE v.4.03 | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE v.4.03 | Non-systematic Assessment |
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| Frost Injury | Injury, poisoning and procedural complications | CTCAE v.4.03 | Non-systematic Assessment | Skin burn |
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| Hematoma | Vascular disorders | CTCAE v.4.03 | Non-systematic Assessment |
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| Rash & Pruritus | Skin and subcutaneous tissue disorders | CTCAE v.4.03 | Non-systematic Assessment |
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| Injection site reaction | General disorders | CTCAE v.4.03 | Non-systematic Assessment | Including tenderness and skin reactions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | IceCure Medical | +972-4-623-0333 | ronitl@icecure-medical.com |
| Mar 17, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Caucasian |
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| Hispanic |
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| Native American |
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| Unknow |
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| Not specified |
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