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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Liver and Intrahepatic Bile Duct Carcinoma

Treatments

Radiation: Computed Tomography Perfusion Imaging
Procedure: Liver Biopsy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03990623
P30CA016672 (U.S. NIH Grant/Contract)
2018-0399
NCI-2019-02648 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Diagnostic (CT perfusion scans, liver biopsy)
Experimental group
Description:
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.
Treatment:
Procedure: Liver Biopsy
Radiation: Computed Tomography Perfusion Imaging

Trial contacts and locations

1

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Central trial contact

Steven Y Huang, MD

Data sourced from clinicaltrials.gov

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