CT Perfusion Scans in Detecting Changes in Blood Flow to the Liver After Portal Vein Embolization

Liver and Intrahepatic Bile Duct Carcinoma Clinical Trial

Official title:

To Evaluate Perfusion Changes to the Liver Following Pre-Operative Portal Vein Embolization for Patients With Liver Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990623
• Other study ID #: 2018-0399
• Secondary ID: NCI-2019-0264820
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2022
• Source: M.D. Anderson Cancer Center
• Contact: Steven Y Huang, MD
• Phone: 713-794-1152
• Email: syhuang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies the use of computed tomography (CT) perfusion scans in detecting changes in blood flow to the liver after portal vein embolization in patients with liver cancer. CT perfusion scans use a standard contrast drug given by vein to measure blood flow to the liver. CT perfusion scans may predict the rate and amount of growth of new, healthy tissue on one side of the liver after a portal vein embolization and detect change to the size of the liver tumor as result of the procedure.

Description:

PRIMARY OBJECTIVES:

I. To assess whether perfusion changes to the liver following portal vein embolization (PVE) correlate with hypertrophy of the future liver remnant (FLR).

SECONDARY OBJECTIVES:

I. To assess perfusion changes to liver tumors following PVE. II. To assess whether PVE may affect tumor growth.

OUTLINE:

Prior to PVE, patients undergo CT perfusion scan of the liver and liver biopsy over 15 minutes. Patients undergo a second CT perfusion scan immediately after PVE and a third CT perfusion scan 3-6 weeks post PVE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients planned to undergo major liver resection for cancer who need PVE to increase the size of the FLR prior to surgery.

• Patients who are able to understand and give consent to participate in the study.

Exclusion Criteria:

• Pregnant or nursing.

• Allergy to iodinated contrast which cannot be safely pre-medicated.

• History of severe renal dysfunction (glomerular filtration rate [GFR] < 30 mL/min/1.73 square meters). Patients with a GFR between 30-50 mL/min/1.73 square meters will receive the standard contrast-induced nephropathy prophylaxis at our institution (i.e. N-acetylcysteine and sodium bicarbonate [150 mEq/L] in D5W intravenous).

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Liver and Intrahepatic Bile Duct Carcinoma

Intervention

Radiation:
• Computed Tomography Perfusion Imaging
Undergo perfusion CT

Procedure:
• Liver Biopsy
Undergo liver biopsy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion changes to the liver following portal vein embolization (PVE)	Will assess whether perfusion changes to the liver following PVE correlate with hypertrophy of the future liver remnant (FLR). Perfusion and FLR hypertrophy are two continuous variables. Each patient will serve as his/her own control. Perfusion to the liver (1) before PVE, (2) immediately after PVE, and (3) 3-6 weeks following PVE will be measured and compared. The changes in perfusion will be compared with FLR hypertrophy at the 3-6 week time point to assess correlation.	Baseline up to 6 weeks post PVE
Secondary	Changes to tumor cellular proliferation following PVE	Will assess perfusion changes to liver tumors following PVE and whether this may affect tumor growth kinetics. Each patient will serve as his/her own control. Perfusion to the liver tumor(s) (1) before PVE, (2) immediately after PVE, and (3) 3-6 weeks following PVE will be measured and compared. Since a percutaneous biopsy will be performed of a single liver tumor before PVE and the tumor explant will be available following surgical resection, changes to tumor cellular proliferation following PVE can be assessed.	Baseline up to 6 weeks post PVE

External Links

•   MD Anderson Cancer Center Website