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

NCT ID: NCT03990623

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-21

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver and Intrahepatic Bile Duct Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (CT perfusion scans, liver biopsy)

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.

Group Type EXPERIMENTAL

Computed Tomography Perfusion Imaging

Intervention Type RADIATION

Undergo perfusion CT

Liver Biopsy

Intervention Type PROCEDURE

Undergo liver biopsy

Interventions

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Computed Tomography Perfusion Imaging

Undergo perfusion CT

Intervention Type RADIATION

Liver Biopsy

Undergo liver biopsy

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy of Liver

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Y Huang, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Steven Y Huang, MD

Role: CONTACT

713-794-1152

Facility Contacts

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Steven Y. Huang, MD

Role: primary

713-794-1152

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-02648

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0399

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-0399

Identifier Type: -

Identifier Source: org_study_id

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