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Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

8. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Glendale, California, Forenede Stater, 91206
        • Rekruttering
        • Glendale Adventist Medical Center d/b/a Adventist Health Glendale
        • Kontakt:
        • Ledende efterforsker:
          • Dennis Holmes, Doctor, MD
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Rekruttering
        • The West Clinic, PC dba West Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Richard Gilmore, Doctor, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Provision of a signed and dated informed consent form.
  2. Age ≥70

  3. 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.
  4. Lesions must be sonographically visible at the time of treatment
  5. Clinically negative lymph node (N0).

Exclusion Criteria:

  1. Presence of lobular carcinoma.
  2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
  3. Evidence of lymphovascular invasion.
  4. Presence of multifocal and/or multicentric breast cancer.
  5. Presence of multifocal suspicious calcifications.
  6. Presence of inflammatory features.
  7. Previous ipsilateral breast radiation
  8. Neoadjuvant endocrine treatment is provided to reduce the tumor size.
  9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
  10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
  11. Allergy to local anesthesia.
  12. Any other reason defined as inoperable declared by a physician.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Low-risk, Early satge breast cancer
FDA-Approved cryoablation procedure for the indicated population
Enhed: Cryoablation

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Tidsramme: 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
Tidsramme: 5 Years
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
5 Years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Primary Tumor Ablation Rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 5 Years
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
5 Years
Patient's satisfaction with cosmetic outcomes
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 5 Years
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
5 Years
Disease-Free Survival (DFS) rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IceCure Medical Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2034

Studieafslutning (Anslået)

1. september 2034

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICM-BC-003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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