Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829291
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-02-27
Brief Title:
Alpha Radiation Emitters Device for the Treatment of Liver Metastases DaRT
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 Liver Metastases
Status:
RECRUITING
Status Verified Date:
2024-05
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 single center study enrolling up to 10 patients The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade1 and to evaluate the radiological response of liver metastases using the RECIST criteria
Detailed Description:
This study is a Prospective Open label one arm single center study to evaluate the feasibility and safety of Diffusing Alpha Radiation Emitters for the treatment of Liver Metastases
Alpha Tau Medical proposes a unique treatment methodology for patients with liver metastases - Diffusing Alpha-emitters Radiation Therapy DaRT - whereby alpha particles are used to destroy solid tumors The concept is predicated on the use of DaRT radioactive sources for radiotherapy
DaRT is based on a nuclear decay chain originating with thorium-228 191 years half-life Outside of negligible non-significant trace amounts the thorium-228 remains confined to the Alpha Tau Medical manufacturing facility and is used to generate radium-224 which is coated onto 316LVM stainless steel wires Alpha DaRT Seeds
The Primary endpoint of the study is 1 Feasibility assessments of the ability to achieve full volume coverage of liver metastases volume
2 Safety of the Alpha DaRT Seeds as therapy for liver metastases Safety will be assessed and recorded according to CTCAE V5
Alpha Tau Medical proposes a unique treatment methodology for patients with liver metastases - Diffusing Alpha-emitters Radiation Therapy DaRT - whereby alpha particles are used to destroy solid tumors The concept is predicated on the use of DaRT radioactive sources for radiotherapy
DaRT is based on a nuclear decay chain originating with thorium-228 191 years half-life Outside of negligible non-significant trace amounts the thorium-228 remains confined to the Alpha Tau Medical manufacturing facility and is used to generate radium-224 which is coated onto 316LVM stainless steel wires Alpha DaRT Seeds
The Primary endpoint of the study is 1 Feasibility assessments of the ability to achieve full volume coverage of liver metastases volume
2 Safety of the Alpha DaRT Seeds as therapy for liver metastases Safety will be assessed and recorded according to CTCAE V5
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