Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
8 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
400
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ronit Lipson, Clinical Trial Manager
- Telefoonnummer: +972-522337768
- E-mail: ronitl@Icecure-medical.com
Studie Contact Back-up
- Naam: Eidan Loushi Clinical Operations Specialist, M.Sc.
- Telefoonnummer: +972-548118632
- E-mail: eidanl@icecure-medical.com
Studie Locaties
-
-
California
-
Glendale, California, Verenigde Staten, 91206
- Werving
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
-
Contact:
- Lily Villalobos
- Telefoonnummer: 818-539-9185
- E-mail: villall3@ah.org
-
Hoofdonderzoeker:
- Dennis Holmes, Doctor, MD
-
-
Tennessee
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Germantown, Tennessee, Verenigde Staten, 38138
- Werving
- The West Clinic, PC dba West Cancer Center
-
Contact:
- Lucy Lasher
- Telefoonnummer: 901-683-0055
- E-mail: IRBApprovals@westclinic.com
-
Hoofdonderzoeker:
- Richard Gilmore, Doctor, MD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Tijdsspanne: 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
Tijdsspanne: 5 Years
|
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
|
5 Years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complete Primary Tumor Ablation Rate
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 5 Years
|
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
|
5 Years
|
|
Patient's satisfaction with cosmetic outcomes
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 5 Years
|
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
|
5 Years
|
|
Disease-Free Survival (DFS) rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
17 juli 2026
Primaire voltooiing (Geschat)
1 juli 2034
Studie voltooiing (Geschat)
1 september 2034
Studieregistratiedata
Eerst ingediend
12 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2026
Eerst geplaatst (Werkelijk)
5 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2026
Laatste update ingediend die voldeed aan QC-criteria
8 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ICM-BC-003
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .