A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).

• Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion

• Target lesion is technically amenable for Alpha DaRT sources implantation.

• Measurable lesion per RECIST (version 1.1) criteria

• Lesion size ≤ 5 cm in the longest diameter

• Interstitial radiation indication validated by a multidisciplinary team.

• ECOG Performance Status Scale 0 -2

• Life expectancy is more than 6 months

• WBC ≥ 3500/μl, granulocyte ≥ 1500/μl

• Platelet count ≥60,000/μl

• Creatinine ≤1.9 mg/dL

• AST and ALT ≤ 2.5 X upper limit of normal (ULN)

• INR \< 1.4 for patients not on Warfarin

• Age ≥18 years old

• 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 initiation of Alpha DaRT therapy.

• 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 DaRT insertion.

Locations
United States
Arizona
Banner MD Anderson Cancer Center
NOT_YET_RECRUITING
Gilbert
City of Hope
NOT_YET_RECRUITING
Goodyear
Honor Health
NOT_YET_RECRUITING
Scottsdale
California
Cedars-Sinai
NOT_YET_RECRUITING
Los Angeles
Florida
Advent Health Cancer Institute
NOT_YET_RECRUITING
Orlando
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Minnesota
Mayo Clinic Rochester
NOT_YET_RECRUITING
Rochester
New York
Bassett Healthcare Network
RECRUITING
Cooperstown
Lenox hill Hospital
NOT_YET_RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Texas
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Texas Oncology
NOT_YET_RECRUITING
Houston
University Cancer and Diagnostic
RECRUITING
Houston
Other Locations
Canada
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
Israel
Hadassah Ein Kerem
RECRUITING
Jerusalem
Contact Information
Primary
Liron Dimnik
LironD@alphatau.com
+972-2-3737-7000
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: Patients with locally advanced pancreatic adenocarcinoma
Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
Experimental: Patients with metastatic pancreatic adenocarcinoma
Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
Related Therapeutic Areas
Sponsors
Leads: Alpha Tau Medical LTD.

This content was sourced from clinicaltrials.gov

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