Intra-arterial Perfusion in Interventional Radiology

NCT05458791 | Unknown FDA Device

• 1 other identifier: SHA0010
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Computed Tomography; Arterial Perfusion; Liver; Interventional Radiology

Outcome Measures

Primary Outcomes (1)

• Quantification of Parameters for Intra-arterial Perfusion

  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.

  1 Day to 1 year

Secondary Outcomes (1)

• Impact of low dose radiation technique on intra-arterial perfusion parameters

  1 Day to 1 Year

Study Arms (2)

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)

Device: Intra-arterial Perfusion

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)

Device: Intra-arterial Perfusion

Interventions

Intra-arterial Perfusion DEVICE

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.

Low Dose Intra-arterial Perfusion; Standard Dose Intra-arterial Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 20 patients with primary or secondary liver tumor(s) who undergo TACE intervention will be assigned to one of each group

You may qualify if:

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

You may not qualify if:

• Not eligible for TACE procedure.
• Any residual ethiodized oil accumulation in the liver
• No prior IA treatment in the last year

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (1)

• Moawad AW, Szklaruk J, Lall C, Blair KJ, Kaseb AO, Kamath A, Rohren SA, Elsayes KM. Angiogenesis in Hepatocellular Carcinoma; Pathophysiology, Targeted Therapy, and Role of Imaging. J Hepatocell Carcinoma. 2020 Apr 23;7:77-89. doi: 10.2147/JHC.S224471. eCollection 2020.

  PMID: 32426302 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rajesh P Shah, MD

  VA Palo Alto Health Care System - Interventional Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh P Shah, MD

CONTACT

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

Calvert Lee

CONTACT

650-493-5000; clee@pavir.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 14, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)