Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
8 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
400
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ronit Lipson, Clinical Trial Manager
- Numéro de téléphone: +972-522337768
- E-mail: ronitl@Icecure-medical.com
Sauvegarde des contacts de l'étude
- Nom: Eidan Loushi Clinical Operations Specialist, M.Sc.
- Numéro de téléphone: +972-548118632
- E-mail: eidanl@icecure-medical.com
Lieux d'étude
-
-
California
-
Glendale, California, États-Unis, 91206
- Recrutement
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
-
Contact:
- Lily Villalobos
- Numéro de téléphone: 818-539-9185
- E-mail: villall3@ah.org
-
Chercheur principal:
- Dennis Holmes, Doctor, MD
-
-
Tennessee
-
Germantown, Tennessee, États-Unis, 38138
- Recrutement
- The West Clinic, PC dba West Cancer Center
-
Contact:
- Lucy Lasher
- Numéro de téléphone: 901-683-0055
- E-mail: IRBApprovals@westclinic.com
-
Chercheur principal:
- Richard Gilmore, Doctor, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Délai: 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
Délai: 5 Years
|
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
|
5 Years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete Primary Tumor Ablation Rate
Délai: 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)
Délai: The day of the procedure
|
Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes
|
The day of the procedure
|
|
Number of hospitalization days following the procedure
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 5 Years
|
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
|
5 Years
|
|
Patient's satisfaction with cosmetic outcomes
Délai: 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)
Délai: 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
Délai: 5 Years
|
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
|
5 Years
|
|
Disease-Free Survival (DFS) rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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).
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 juillet 2026
Achèvement primaire (Estimé)
1 juillet 2034
Achèvement de l'étude (Estimé)
1 septembre 2034
Dates d'inscription aux études
Première soumission
12 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
5 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ICM-BC-003
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
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