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出境医 / 临床实验 / CT Perfusion Scans in Detecting Changes in Blood Flow to the Liver After Portal Vein Embolization

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

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.

Condition or disease Intervention/treatment Phase
Liver and Intrahepatic Bile Duct Carcinoma Radiation: Computed Tomography Perfusion Imaging Procedure: Liver Biopsy Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: To Evaluate Perfusion Changes to the Liver Following Pre-Operative Portal Vein Embolization for Patients With Liver Cancer
Actual Study Start Date : July 21, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Radiation: Computed Tomography Perfusion Imaging
Undergo perfusion CT

Procedure: Liver Biopsy
Undergo liver biopsy
Other Name: Biopsy of Liver
Outcome Measures
Primary Outcome Measures :
  1. Perfusion changes to the liver following portal vein embolization (PVE) [ Time Frame: Baseline up to 6 weeks post 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 :
  1. Changes to tumor cellular proliferation following PVE [ Time Frame: Baseline up to 6 weeks post 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Contacts
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Contact: Steven Y Huang, MD 713-794-1152 syhuang@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Steven Y. Huang, MD    713-794-1152    syhuang@mdanderson.org   
Principal Investigator: Steven Y. Huang, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Steven Y Huang, MD M.D. Anderson Cancer Center
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE July 21, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		Perfusion changes to the liver following portal vein embolization (PVE) [ Time Frame: Baseline up to 6 weeks post 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		Changes to tumor cellular proliferation following PVE [ Time Frame: Baseline up to 6 weeks post 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT Perfusion Scans in Detecting Changes in Blood Flow to the Liver After Portal Vein Embolization
Official Title  ICMJE To Evaluate Perfusion Changes to the Liver Following Pre-Operative Portal Vein Embolization for Patients With Liver Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Liver and Intrahepatic Bile Duct Carcinoma
Intervention  ICMJE
  • Radiation: Computed Tomography Perfusion Imaging
    Undergo perfusion CT
  • Procedure: Liver Biopsy
    Undergo liver biopsy
    Other Name: Biopsy of Liver
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Radiation: Computed Tomography Perfusion Imaging
  • Procedure: Liver Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven Y Huang, MD 713-794-1152 syhuang@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990623
Other Study ID Numbers  ICMJE 2018-0399
NCI-2019-02648 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0399 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Steven Y Huang, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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