Recruiting

Intra-Arterial Perfusion

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT05458791

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-arterial Perfusion

Study Details

Brief summary:

Patients are being asked to participate in a study to better determine blood flow going to tumors in the liver. They will undergo an embolization procedure in interventional radiology where the goal is to provide treatment directly into the liver tumor. These treatments are delivered into the blood vessels feeding the tumors. Improving these treatments relies on better understanding the blood flow into the tumor. By understanding how much blood flows into the tumors, the goal is to make sure there is the best chance of killing the tumor. The investigators are attempting to use a special type of CT scan during the procedure to determine the blood flow to the tumors.

Conditions

Hepatocellular Carcinoma

Study ID

NCT05458791

Start date

Jul 1, 2022

Status verified date

Jul, 2022

Completion date

Jan, 2024

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > or = 18 years
2. primary or secondary liver tumor(s)
3. Trans-arterial chemoembolization (TACE) or trans-catheter radio embolization (TARE) approved by multidisciplinary tumor board
4. Tumor in an area without prior surgical or ablative therapy
5. At least 1 tumor greater than 1.5 cm in greatest diameter

Exclusion Criteria:
6. Not eligible for TACE procedure.
7. Same additional exclusion criteria as aim 1
8. Any residual ethiodized oil accumulation in the liver
9. No prior IA treatment in the last year

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard Dose Intra-arterial Perfusion

All patients will undergo standard of care interventional treatment for liver cancer. The procedure will take place utilizing fluoroscopic and CT guidance. During their procedure, patients will have intra-arterial CT perfusion maps derived of the liver including the region of the tumor. (n=10)

Low Dose Intra-arterial Perfusion

Investigate the impacts on contrast and radiation doses and the robustness of reconstruction algorithms on intra-arterial CT perfusion using a lower radiation dose technique. (N=10)

Interventions

Intra-arterial Perfusion

All patients will undergo standard of care locoregional intra-arterial (IA) treatment for HCC. The procedure will take place utilizing fluoroscopic and CT guidance. Following catheterization of the femoral or radial artery, CT angiography of the hepatic circulation will be performed to define the hepatic vascular anatomy. Intra-arterial CT perfusion will be performed prior to IA treatment by the interventional radiologist to understand the dynamics of hepatic circulation or to manage the IA treatment strategy.

Primary outcome measure

  • Quantification of Parameters for Intra-arterial Perfusion [ Time Frame: 1 Day to 1 year ]

Central Contacts and Locations

Central contacts

Rajesh P Shah, MD

650-493-5000rajesh.shah2@va.gov

Calvert Lee

650-493-5000clee@pavir.org

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Raj P Shah, MD

650-493-5000rajesh.shah2@va.gov

Calvert Lee

650-493-5000clee@pavir.org

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Jul 19, 2022

Last verified

Jul, 2022

Keywords

  • Computed Tomography
  • Arterial Perfusion
  • Liver
  • Interventional Radiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2022-07-19.