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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06202118
Recruitment Status : Not yet recruiting
First Posted : January 11, 2024
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Recurrent Breast Cancer Breast Carcinoma Device: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : February 2024
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06202118


Contacts
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Contact: Liron Dimnik +972542688602 LironD@alphatau.com
Contact: Aviya Hoida +972547869466 aviyah@alphatau.com

Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel, 9777605
Contact: Tanir Michal Eloise, MD       tanir@hadassah.org.il   
Sponsors and Collaborators
Alpha Tau Medical LTD.
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT06202118    
Other Study ID Numbers: CTP-BRST-07
First Posted: January 11, 2024    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
Alpha radiation
Breast cancer
Newly Diagnosed Breast Carcinoma
Breast carcinoma
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases