A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
NCT ID: NCT06202118
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-02-19
2026-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
120 Years
ALL
No
Sponsors
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Alpha Tau Medical LTD.
INDUSTRY
Responsible Party
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Locations
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Hadassah Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTP-BRST-07
Identifier Type: -
Identifier Source: org_study_id
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