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

Primary Purpose

Liver and Intrahepatic Bile Duct Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography Perfusion Imaging
Liver Biopsy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver and Intrahepatic Bile Duct Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CT perfusion scans, liver biopsy)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 17, 2019
Last Updated
April 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03990623
Brief Title
CT Perfusion Scans in Detecting Changes in Blood Flow to the Liver After Portal Vein Embolization
Official Title
To Evaluate Perfusion Changes to the Liver Following Pre-Operative Portal Vein Embolization for Patients With Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2018 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver and Intrahepatic Bile Duct Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CT perfusion scans, liver biopsy)
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Computed Tomography Perfusion Imaging
Intervention Description
Undergo perfusion CT
Intervention Type
Procedure
Intervention Name(s)
Liver Biopsy
Other Intervention Name(s)
Biopsy of Liver
Intervention Description
Undergo liver biopsy
Primary Outcome Measure Information:
Title
Perfusion changes to the liver following portal vein embolization (PVE)
Description
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.
Time Frame
Baseline up to 6 weeks post PVE
Secondary Outcome Measure Information:
Title
Changes to tumor cellular proliferation following PVE
Description
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.
Time Frame
Baseline up to 6 weeks post PVE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Y Huang, MD
Phone
713-794-1152
Email
syhuang@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Y Huang, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Y. Huang, MD
Phone
713-794-1152
Email
syhuang@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Steven Y. Huang, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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