Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743842
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-02-15
Brief Title:
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
Status:
RECRUITING
Status Verified Date:
2024-09
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:
To learn if using the TriNav Infusion System TriNav catheter for the injection of the surrogatetest dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter
Detailed Description:
Primary Objectives
To determine the percentage of tumors that demonstrate quantitative mean dose concordance within 20 using voxel-level quantitative SPECTCT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM PEDDTM device
Secondary Objectives
To determine the correlation of TN ratios of all tumors 3cm based on 99mTc-MAA SPECTCT and Y90 SPECTCT imaging
To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECTCT
To assess safety of TriNav catheter in this study population
To determine the percentage of tumors that demonstrate quantitative mean dose concordance within 20 using voxel-level quantitative SPECTCT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM PEDDTM device
Secondary Objectives
To determine the correlation of TN ratios of all tumors 3cm based on 99mTc-MAA SPECTCT and Y90 SPECTCT imaging
To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECTCT
To assess safety of TriNav catheter in this study population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-01620 | OTHER | NCI-CTRP Clinical Trials Registry | None |