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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach using intratumoral diffusing alpha radiation emitter devices for advanced pancreatic cancer. This prospective, interventional, open-label, single-arm, multicenter study aims to assess the feasibility and safety of these DaRT seeds in patients with locally advanced or metastatic pancreatic adenocarcinoma who have received chemotherapy or are medically unfit for it, and whose tumors are not suitable for surgery or who refuse surgery. The treatment involves the insertion of radioactive DaRT seeds directly into the tumor. These seeds release short-lived alpha-emitting atoms inside the tumor. The study includes a screening period, a procedure visit for DaRT seed insertion, an acute follow-up phase lasting 4 to 8 weeks, and a long-term follow-up phase of 3 months after insertion. A total of 15 patients will be enrolled and monitored throughout these phases. Participants will undergo evaluations including safety monitoring for adverse events up to 3 months, and assessments of treatment feasibility based on seed placement. Researchers will also measure efficacy outcomes at 1 month and 3 months after insertion and immediately following the procedure. The total participation duration is about 3 months from the time of DaRT insertion, with close follow-up to track treatment effects and patient safety.
CONDITIONS
Brief 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 confirmed locally advanced or metastatic pancreatic adenocarcinoma
- Received at least one line of chemotherapy or medically unfit for further chemotherapy
- Tumor not suitable for radical surgery or patient refuses surgery
- Target lesion suitable for at least 50% coverage by Alpha DaRT seeds
- Interstitial radiation indication approved by a multidisciplinary team
- Measurable lesion per RECIST v1.1 criteria
- Lesion size 5 cm or less in longest diameter
- Age 18 years or older
- ECOG performance status 2 or less
- Life expectancy more than 6 months
- White blood cell count 3500/µl or higher
- Granulocyte count 1500/µl or higher
- Platelet count 60,000/µl or higher
- Creatinine clearance 60 cc/min or higher, or 40 cc/min with stable creatinine levels
- AST and ALT levels up to 2.5 times upper limit of normal
- INR less than 1.4 if not on Warfarin
- Willing and able to sign informed consent
- Women of childbearing potential must have negative pregnancy test and use contraception
- Agreement to use adequate contraception before, during, and 3 months after therapy
You will not qualify if you...
- Chemotherapy or immunotherapy within the past 4 weeks
- Brain metastases
- Borderline unresectable pancreatic cancer or candidates for surgery unless surgery refused
- Known allergy to any treatment components
- Ongoing systemic immunosuppressive therapy except brief corticosteroids
- Significant cardiovascular disease such as severe heart failure or recent heart attack
- Uncontrolled illnesses including active infections or psychiatric/substance abuse disorders
- Additional progressing malignancies requiring treatment, except certain skin and cervical cancers
- Need for treatments conflicting with study endpoints
- Refusal or inability to use contraception as required
- Participation in conflicting interventional studies within past 30 days
- High risk of not following study protocol
- Breastfeeding or women unwilling/unable to use contraception after radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the intratumoral insertion procedure of Diffusing Alpha Radiation Emitters (DaRT seeds) to treat advanced pancreatic cancer.
1 procedure visit (in-person)
Duration - 4 to 8 weeks
Participants are monitored for safety and efficacy during an acute follow-up phase after the DaRT seed insertion.
Multiple visits during follow-up phase (in-person)
Duration - Up to 3 months
Participants continue to be monitored for safety and treatment effects for up to 3 months after the DaRT seed insertion.
Follow-up visits as scheduled (in-person)
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
A
Aviya Hoida
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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