A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
Recruiting · NCT06202118 · Interventional (participants receive a specific treatment) · Lead sponsor: Alpha Tau Medical LTD.
View the official record on ClinicalTrials.gov →Interventions studied
Diffusing Alpha Radiation Emitters Therapy (DaRT)
What this trial is about
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.
Who can take part
Age range
65 Years to 120 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Hadassah Medical Center - Jerusalem, Israel