Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
Study NCT ID:
NCT06755359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
Sponsor:
Alpha Tau Medical LTD.
Organization:
Study Overview
Official Title:
A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .
Detailed Description:
This study will be a prospective, interventional, open label, single arm, multiple center study.
Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.
Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: