Actively Recruiting
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer
Led by Alpha Tau Medical LTD. · Updated on 2025-12-08
15
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
CONDITIONS
Official Title
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically proven locally advanced or metastatic pancreatic adenocarcinoma
- Patients must have received at least one line of chemotherapy OR are medically unfit for further chemotherapy
- Tumor is not resectable by radical surgery or patient refuses surgery
- Target lesion amenable for at least 50% coverage by Alpha DaRT seeds as determined by physician
- Interstitial radiation indication validated by a multidisciplinary team
- Measurable lesion per RECIST version 1.1 criteria
- Lesion size of 5 cm or less in longest diameter
- Age 18 years or older
- ECOG Performance Status Scale of 2 or less
- Life expectancy greater than 6 months
- White blood cell count of 3500/µl or higher
- Granulocyte count of 1500/µl or higher
- Platelet count of 60,000/µl or higher
- Creatinine clearance of 60 cc/min or higher, or 40 cc/min or higher if stable over past 3 weeks
- AST and ALT levels at or below 2.5 times the upper limit of normal
- INR below 1.4 for patients not on Warfarin
- Willing and able to sign an informed consent form
- Women of childbearing potential must have negative pregnancy test before implantation and use contraception for 3 months after
- Agreement to use adequate contraception prior to study entry, during participation, and for 3 months after therapy
You will not qualify if you...
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Brain metastases
- Borderline unresectable pancreatic cancer or candidates for surgery unless surgery is refused
- Known hypersensitivity to treatment components
- Undergoing systemic immunosuppressive therapy except brief corticosteroids use
- Significant cardiovascular disease (e.g., severe heart failure, uncontrolled coronary disease, recent heart attack)
- Uncontrolled illnesses including active infections or psychiatric/substance abuse disorders interfering with study
- Additional progressing malignancy requiring active treatment except certain skin cancers or in situ cervical cancer
- Need for treatments conflicting with study endpoints
- Refusal to use adequate contraception as required
- Participation in conflicting interventional studies within past 30 days
- High likelihood of not complying with the study protocol
- Breastfeeding women or women unwilling/unable to use contraception for 3 months after radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Wolfson Medical Center
Holon, Israel
Not Yet Recruiting
2
Hadassah Ein Kerem
Jerusalem, Israel
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
A
Aviya Hoida
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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