A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer

NCT05657743 | Recruiting

• 1 other identifier: CTP-PANC-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

pancreatic cancer; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreas Neoplasm; Alpha radiation; Pancreas Metastases

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

  From Day 0

• Safety - Adverse events

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

  up to 3 months

Secondary Outcomes (3)

• Efficacy -Alpha DaRT seeds

  1 month and 3 months]

• Efficacy-Alpha DaRT seeds

  1 month and 3 months

• Efficacy-Alpha DaRT seeds

  immediately following the insertion procedure

Other Outcomes (4)

• Exploratory objective-Blood samples will be collected for immune response biomarker analyses. Blood samples will be analyzed using FACS and change to the following immune biomarkers will be assessed: CD3, CD4, CD8, CD69, CD137

  1 month

• Exploratory objective

  1&3 months

• Blood radioactivity measurements

  week 0 and week 7, 1 and 2 months

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) 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

DaRT Seeds

Eligibility Criteria

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

You may qualify if:

• Histologically and/or cytologically proven locally advanced or metastatic pancreatic adenocarcinoma
• Patients must have i) received at least one line of chemotherapy 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
• Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
• Interstitial radiation indication validated by a multidisciplinary team
• Measurable lesion per RECIST (version 1.1) criteria
• 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 ≥ 60cc/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
• Brain metastases
• Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless 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 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 (2)

Wolfson Medical Center

Holon, Israel

NOT YET RECRUITING

Hadassah Ein Kerem

Jerusalem, Israel

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

• Aron Popovtzer, MD

  Hadassah University Hospital - Ein-Kerem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

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

Aviya Hoida

CONTACT

+972-2-3737-210; aviyah@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: November 21, 2022
• First Posted: December 20, 2022
• Study Start: August 16, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)