Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229080
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-01-05
Brief Title:
SEGWAYShort-term Embolization Using Gelatin Particles for floW modulAtion During Y90 Radioembolization
Sponsor:
Next Biomedical Co Ltd
Organization:
Next Biomedical Co Ltd
Study Overview
Official Title:
Short-term Embolization Using Gelatin Particles for floW modulAtion During Y90 Radioembolization SEGWAY a Pliot Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Short-acting coloration for normal liver protection in liver cancer patients undergoing radioembolization therapy a study on the effectiveness of all substances
Detailed Description:
Patients liver function can be preserved when delivery of radioembolic agents to the non-tumorous liver is minimized This is a single-center single-arm clinical trial to evaluate the efficacy of short-acting embolization particles to temporarily embolize the hepatic arteries toward the non-tumorous liver in patients with hepatocellular carcinoma treated by radioembolization of a large perfused volume A transient embolic effect will be evaluated by digital subtraction angiography during the procedure Absorbed doses of the transiently protected non-tumorous liver and unprotected non-tumorous liver will be compared by pre-treatment SPECT-CT 99mTc injection without transient embolization and post-treatment PET-CT Y90 injection with transient embolization In addition liver volume and function changes for six months will be estimated using gadoxetic acid-enhanced dynamic MRI
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