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

8. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Glendale, California, Forente stater, 91206
        • Rekruttering
        • Glendale Adventist Medical Center d/b/a Adventist Health Glendale
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dennis Holmes, Doctor, MD
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • Rekruttering
        • The West Clinic, PC dba West Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Richard Gilmore, Doctor, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Low-risk, Early satge breast cancer
FDA-Approved cryoablation procedure for the indicated population
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IceCure Medical Ltd.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. juli 2026

Primær fullføring (Antatt)

1. juli 2034

Studiet fullført (Antatt)

1. september 2034

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ICM-BC-003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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