Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
2026년 9월 8일 업데이트: IceCure Medical Ltd.
Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.
This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment.
In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.
연구 개요
연구 유형
중재적
등록 (추정된)
400
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ronit Lipson, Clinical Trial Manager
- 전화번호: +972-522337768
- 이메일: ronitl@Icecure-medical.com
연구 연락처 백업
- 이름: Eidan Loushi Clinical Operations Specialist, M.Sc.
- 전화번호: +972-548118632
- 이메일: eidanl@icecure-medical.com
연구 장소
-
-
California
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Glendale, California, 미국, 91206
- 모병
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
-
연락하다:
- Lily Villalobos
- 전화번호: 818-539-9185
- 이메일: villall3@ah.org
-
수석 연구원:
- Dennis Holmes, Doctor, MD
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Tennessee
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Germantown, Tennessee, 미국, 38138
- 모병
- The West Clinic, PC dba West Cancer Center
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연락하다:
- Lucy Lasher
- 전화번호: 901-683-0055
- 이메일: IRBApprovals@westclinic.com
-
수석 연구원:
- Richard Gilmore, Doctor, MD
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Provision of a signed and dated informed consent form.
- Age ≥70
Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:
- Unifocal primary disease
- Tumor size ≤1.5 cm in greatest diameter
- Estrogen receptor positive, Progesterone receptor positive, and HER2 negative
- Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.
- Lesions must be sonographically visible at the time of treatment
- Clinically negative lymph node (N0).
Exclusion Criteria:
- Presence of lobular carcinoma.
- Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
- Evidence of lymphovascular invasion.
- Presence of multifocal and/or multicentric breast cancer.
- Presence of multifocal suspicious calcifications.
- Presence of inflammatory features.
- Previous ipsilateral breast radiation
- Neoadjuvant endocrine treatment is provided to reduce the tumor size.
- Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
- Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
- Allergy to local anesthesia.
- Any other reason defined as inoperable declared by a physician.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Low-risk, Early satge breast cancer
FDA-Approved cryoablation procedure for the indicated population
|
Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
기간: 5 Years
|
The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
|
5 Years
|
|
Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate
기간: 5 Years
|
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
|
5 Years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Complete Primary Tumor Ablation Rate
기간: 6 Months
|
The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up.
|
6 Months
|
|
Procedure duration (minutes)
기간: The day of the procedure
|
Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes
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The day of the procedure
|
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Number of hospitalization days following the procedure
기간: 6 Months
|
Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge.
|
6 Months
|
|
Days to resume normal activity
기간: 6 Months
|
Number of days after cryoablation until return to routine daily activities, as reported by the patient.
|
6 Months
|
|
Number of procedure-related outpatient visits
기간: 6 Months
|
Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities
|
6 Months
|
|
Physician's satisfaction with the breast's cosmetic results
기간: 6 Months
|
Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment.
Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent).
|
6 Months
|
|
Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications.
기간: 6 Months
|
Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months.
|
6 Months
|
|
Local recurrence and Second primary breast cancer rates
기간: 5 Years
|
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
|
5 Years
|
|
Patient's satisfaction with cosmetic outcomes
기간: 5 Years
|
Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module.
Scores are reported on a 0 (Worst) to 100 (Best) scale.
|
5 Years
|
|
Patients' Quality of life (QoL)
기간: 5 Years
|
Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being.
BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale.
|
5 Years
|
|
Locoregional recurrence (LRR) rate
기간: 5 Years
|
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
|
5 Years
|
|
Disease-Free Survival (DFS) rate
기간: 5 Years
|
The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer.
|
5 Years
|
|
Overall Survival (OS) rate
기간: 5 Years
|
The percentage of participants who did not experience death due to any cause up to 5 years.
|
5 Years
|
|
Breast cancer survival rate
기간: 5 Years
|
The percentage of patients who did not experience death due to breast cancer up to 5 years.
|
5 Years
|
|
Rate of discontinuation of routine follow-up procedures
기간: 5 Years
|
The percentage of patients who discontinue routine breast-related follow-up procedures.
|
5 Years
|
|
Serious adverse events (related/non-related to device and procedure).
기간: 5 Years
|
The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure.
|
5 Years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 17일
기본 완료 (추정된)
2034년 7월 1일
연구 완료 (추정된)
2034년 9월 1일
연구 등록 날짜
최초 제출
2026년 5월 12일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 9월 1일
추가 정보
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