NCT06204159

Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE. • Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure? Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.

Detailed description

Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Conditions

• Hepatocellular Carcinoma
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DEVICE	TACE Catheters	End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure. This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-01-31
• Completion: 2026-06-30
• First posted: 2024-01-12
• Last updated: 2025-05-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study