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Trial record 11 of 26 for:    alpha dart
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A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

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ClinicalTrials.gov Identifier: NCT06202118
Recruitment Status : Recruiting
First Posted : January 11, 2024
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Tracking Information
First Submitted Date  ICMJE December 31, 2023
First Posted Date  ICMJE January 11, 2024
Last Update Posted Date May 20, 2024
Actual Study Start Date  ICMJE February 19, 2024
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2023)
  • Feasibility -DaRT seed placement [ Time Frame: immediately following the insertion procedure ]
    Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
  • Safety- Adverse events [ Time Frame: From Day 0 ]
    Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2023)		 Efficacy - Control evaluation [ Time Frame: 3,6,12 and 24 months ]
To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
Official Title  ICMJE A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.
Brief Summary A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
Detailed Description

This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.

The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.

A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Recurrent Breast Cancer
  • Breast Carcinoma
Intervention  ICMJE Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Study Arms  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2023)		 10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
  • Tumor size ≤ 4 centimeters in the longest diameter.
  • Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
  • De-novo or recurrent lesions.
  • Single lesion per quadrant per subject.
  • Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
  • Interstitial implant indication validated by multidisciplinary team.
  • ECOG Performance Status ≤3.
  • Life expectancy ≥12 months.
  • Women Age ≥65 or younger if unfit for standard of care.
  • Willing and have the ability to provide signed Informed Consent.

  • Blood tests values:

    • Leucocytes ≥3000mm3,
    • Absolute neutrophil count ≥1500mm3,
    • Platelets ≥100,000 mm3,
    • Total bilirubin ≤ 1.5xULN,
    • AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
    • Creatinine ≤ 2.0xULN.
    • INR or Prothrombin time ≤1.5xULN

Exclusion Criteria:

  • T4 category with skin involvement.
  • Ductal carcinoma in situ.
  • Inflammatory breast carcinoma.
  • Longest tumor diameter >4 cm.
  • Patients with prior radiation to the same area within the past 6 months.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease
  • Subjects not willing to sign an informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 120 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liron Dimnik +972542688602 LironD@alphatau.com
Contact: Aviya Hoida +972547869466 aviyah@alphatau.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06202118
Other Study ID Numbers  ICMJE CTP-BRST-07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alpha Tau Medical LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alpha Tau Medical LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alpha Tau Medical LTD.
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP