Intratumoral alpha-radiation seed implants for locally advanced pancreatic cancer
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
This trial will try tiny alpha-radiation seed implants placed directly into tumors to see if they are safe and feasible for adults with locally advanced, unresectable pancreatic adenocarcinoma who have already had or cannot tolerate more chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Verona) |
| Trial ID | NCT06026943 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, open-label, single-arm feasibility study enrolling 15 patients with locally advanced, unresectable pancreatic adenocarcinoma. Participants will undergo placement of Diffusing Alpha Radiation Emitter (DaRT) seeds directly into the tumor, followed by clinical and imaging follow-up over three months, with the overall study conducted over 24 months. A safety interim analysis will be performed after the first five patients to review adverse events and procedural issues. Primary outcomes focus on procedural feasibility and safety, with secondary observations of short-term tumor response per RECIST 1.1.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically or cytologically confirmed locally advanced, unresectable pancreatic adenocarcinoma, measurable disease ≤5 cm, ECOG ≤2, who have had at least one line of chemotherapy or are unfit for further chemotherapy and meet the listed laboratory criteria are appropriate candidates.
Not a fit: Patients with tumors larger than 5 cm, poor performance status (ECOG >2), inadequate blood counts or organ/renal function, or disease deemed resectable are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could offer focused tumor control using high-energy alpha particles while minimizing radiation exposure to surrounding healthy tissue.
How similar studies have performed: Early-phase work with DaRT and other intratumoral alpha-emitter approaches has shown promising local control in some solid tumors, but use in pancreatic cancer is largely novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically and/or cytologically proven NCCN locally advanced PC * Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery. * DaRT indication validated by a multidisciplinary team. * Measurable lesion per RECIST (version 1.1) criteria * TC at Verona's center (not been over a month) * Lesion size ≤ 5 cm in the longest diameter * Age ≥18 years old * ECOG Performance Status Scale ≤ 2 * Life expectancy is more than 6 months * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * Platelet count ≥60,000/μl * Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week). * AST and ALT ≤ 2.5 X upper limit of normal (ULN) * INR \< 1.4 for patients not on Warfarin * Subjects are willing and able to sign an informed consent form * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy. * Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. Exclusion Criteria: * Concomitant chemotherapy or immunotherapy within the past 4 weeks * Prior radiation therapy to the pancreas * CA 19-9 \> 1000 Units/ml * Fit for surgical exploration unless the patient refuses surgery * Known hypersensitivity to any of the components of the treatment. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids. * Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months. * Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT. * Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * 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). * Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
Where this trial is running
Verona
- Chirurgia Generale e del Pancreas, Istituto del Pancreas — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Salvatore Paiella, MD — Pancreas Institute - Integrated University Hospital of Verona
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-3737-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.