Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05657743
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2022-11-21
Brief Title:
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer
Sponsor:
Alpha Tau Medical LTD
Organization:
Alpha Tau Medical LTD
Study Overview
Official Title:
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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 employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Detailed Description:
This is a Prospective interventional open label single arm multiple center study The study is designed to evaluate the feasibility and safety of the DaRT seeds for the treatment of advanced pancreatic cancer
The study will be comprised of a screening period DaRT insertion visit acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months The total duration of the study will be 3 months from the DaRT insertion procedure
15 patients with advanced pancreatic cancer will be recruited by the investigational site
Eligible patients who meet inclusionexclusion criteria as assessed during the screening period will be invited to the site for the procedure of DaRT seeds insertion The patients will be monitored for a period of 3 months post insertion
The study will be comprised of a screening period DaRT insertion visit acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months The total duration of the study will be 3 months from the DaRT insertion procedure
15 patients with advanced pancreatic cancer will be recruited by the investigational site
Eligible patients who meet inclusionexclusion criteria as assessed during the screening period will be invited to the site for the procedure of DaRT seeds insertion The patients will be monitored for a period of 3 months post 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?:
None