Radiation: 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 advanced pancreatic cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
* Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
* ECOG performance status ≤ 2
* Measurable lesion per RECIST (version 1.1) criteria
* Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
* ≥ 18 years of age
* Estimated life expectancy of at least 12 weeks
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
* Subjects are willing to sign an informed consent
Exclusion Criteria:
* Prior chemotherapy does not exclude the patient
* Prior abdominal radiation therapy
* Concomitant chemotherapy or immunotherapy
* Borderline resectable pancreatic cancer and medically fit for surgery
* Connective tissue disease (scleroderma, lupus)
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
* High probability of protocol non-compliance (in opinion of investigator)
* Patients not willing to sign an informed consent form
* Women who are pregnant or lactating
Primary outcome measure(s)
Feasibility - DaRT seed placement — Day 0 (Day of insertion) Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
Safety - Adverse events — 3 months Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0
Safety - Adverse events — 3 to 24 months Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion
Trial sites (2)
Facility
City
Region
Status
Centre Hospitalier de l'Université de Montréal (CHUM)
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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