Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT06698458
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Sponsor:
Alpha Tau Medical LTD.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-10
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:
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.
* 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.
Detailed Description:
This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline:
1. Locally advanced
2. Metastatic. 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.
1. Locally advanced
2. Metastatic. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: