Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer

NCT06026943 | Recruiting

• 1 other identifier: CTP-PANC-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer

Conditions

Pancreatic Cancer; Unresectable Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

pancreatic cancer; Unresectable Pancreatic Cancer; Pancreatic Adenocarcinoma; Alpha radiation; Pancreas Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility- DaRT seed placement

  Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging

  Immediately following the insertion procedure

• Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria

  Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria

  from DaRT-insertion up to 48 hours

Secondary Outcomes (4)

• To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer

  1 months and 3 months

• To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels

  1 months and 3 months

• Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds

  immediately following the insertion procedure]

• Efficacy- Alpha DaRT seeds

  from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months

Other Outcomes (1)

• Exploratory Objective -to evaluate the changes in the immune markers by Blood samples for immune response

  1 month

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: DaRT seeds insertion

Interventions

DaRT seeds insertion DEVICE

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

Also known as: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

DaRT Seeds

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Chirurgia Generale e del Pancreas, Istituto del Pancreas

Verona, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Salvatore Paiella, MD

  Pancreas Institute - Integrated University Hospital of Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972-2-3737-7000; LironD@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 7, 2023
• Study Start: December 4, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-08

Locations

IT (1)