Clinical trial · Interventional
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.
NCT06202118CI-TRIAL-00085627recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DaRT Seeds
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- interventionNames
- Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (2)
- measure
- Feasibility -DaRT seed placement
- timeFrame
- immediately following the insertion procedure
- description
- Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
- measure
- Safety- Adverse events
- timeFrame
- From Day 0
- description
- Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.