Breast CancerRecurrent Breast CancerBreast Carcinoma
Investigational drug(s) / intervention(s)
Diffusing Alpha Radiation Emitters Therapy (DaRT)
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 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
Sex
ALL
Min age
65 Years
Max age
120 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Feasibility -DaRT seed placement — immediately following the insertion procedure Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Safety- Adverse events — From Day 0 Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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