Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02200705
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
IceCure Medical Ltd.

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
local Inbreast Breast Tumor Recurrence (IBTR) rate. [ Time Frame: up to 5 years ]
6 months post cryoabltion , then annually for 5 years
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • Complete ablation of primary tumor up to 60 months after cryoablation [ Time Frame: up to 5 years from procedure date. ]
  • Improvement or maintenance of subject's quality of life. [ Time Frame: at 6 months compare to the base line ]
  • Breast cosmetics satisfaction. [ Time Frame: 6 months after cryoablation ]
  • Regional and distant Invasive breast tumor recurrence rate. [ Time Frame: up to 5 years ]
  • Disease-free Survival (DFS),Overall survival including breast Cancer Survival. [ Time Frame: up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial
Official Title  ICMJE Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
Brief Summary To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Ice-Sense3TM
Study Arms  ICMJE single arm, open label
Early stage Breast cancers up to 1.5cm
Intervention: Device: Ice-Sense3TM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
150
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

3. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200705
Other Study ID Numbers  ICMJE ICMBC-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IceCure Medical Ltd.
Study Sponsor  ICMJE IceCure Medical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IceCure Medical Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP