A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
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.
Alpha Tau Medical LTD.
10 participants
Feb 19, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria19
- 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 Criteria8
- 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.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06202118