Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
8 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
400
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ronit Lipson, Clinical Trial Manager
- Número de teléfono: +972-522337768
- Correo electrónico: ronitl@Icecure-medical.com
Copia de seguridad de contactos de estudio
- Nombre: Eidan Loushi Clinical Operations Specialist, M.Sc.
- Número de teléfono: +972-548118632
- Correo electrónico: eidanl@icecure-medical.com
Ubicaciones de estudio
-
-
California
-
Glendale, California, Estados Unidos, 91206
- Reclutamiento
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
-
Contacto:
- Lily Villalobos
- Número de teléfono: 818-539-9185
- Correo electrónico: villall3@ah.org
-
Investigador principal:
- Dennis Holmes, Doctor, MD
-
-
Tennessee
-
Germantown, Tennessee, Estados Unidos, 38138
- Reclutamiento
- The West Clinic, PC dba West Cancer Center
-
Contacto:
- Lucy Lasher
- Número de teléfono: 901-683-0055
- Correo electrónico: IRBApprovals@westclinic.com
-
Investigador principal:
- Richard Gilmore, Doctor, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Periodo de tiempo: 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
Periodo de tiempo: 5 Years
|
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
|
5 Years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Complete Primary Tumor Ablation Rate
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 5 Years
|
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
|
5 Years
|
|
Patient's satisfaction with cosmetic outcomes
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 5 Years
|
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
|
5 Years
|
|
Disease-Free Survival (DFS) rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2034
Finalización del estudio (Estimado)
1 de septiembre de 2034
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ICM-BC-003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .