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Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation (IC-Green)

This study is currently recruiting participants.
Verified July 2017 by University of Michigan Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519219
First Posted: January 26, 2012
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose
The goal of the trial is to assess the effect of radiation treatment on liver function as determined by indocyanine green extraction. The long term goal is to determine if individual assessment of liver function using the IC-Green method, either alone or in combination with other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are superior to the probabilistic method currently in use.

Condition Intervention
Hepatic Irradiation Radiation: Hepatic Irradiation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Baseline IC-GREEN elimination [ Time Frame: 1 day ]
    Most subjects will have five IC-GREEN assessments. Graphical displays will be used to choose the form of a time-dependent model of IC-GREEN elimination. A mixed, possibly nonlinear model, with patient as random effect, will be fit to the data by the maximum likelihood principle. Profile confidence intervals for the parameters will be determined.


Secondary Outcome Measures:
  • Change in IC-green elimination after radiation therapy [ Time Frame: 6 months ]
    Using model parameters, a cumulative distribution function for IC-GREEN elimination at each time point will be determined from the patients who do not contract RILD. This will result in a smooth estimate of the IC-GREEN assay results, from which lower normal bounds (at, for instance, the fifth percentile) can be established.


Estimated Enrollment: 240
Study Start Date: January 2003
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatic Irradiation Radiation: Hepatic Irradiation
Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy

Detailed Description:
Following intravenous injection, IC-GREEN is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). IC-GREEN is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. It undergoes no significant extrahepatic or enterohepatic circulation. Simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Therefore, the serum clearance rate (determined from serial serum concentration measurements at various times after intravenous injection) can serve as a useful index of liver function.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who take part in this study are required to be scheduled for hepatic irradiation.
Criteria

Inclusion Criteria:

  • 18 or older, all gender, ethnicities and races
  • Life expectancy of at least 12 weeks
  • Zubrod performance status ≤ 2
  • Baseline clinical assessments of liver function by complete history and physical examination
  • Laboratory tests to be done within 6 weeks prior to start of radiation: CBC and platelets, liver function tests including SGOT, SGPT, Alkaline Phosphatase, and bilirubin, albumin, BUN, creatinine, PT/PTT, INR

Exclusion Criteria:

  • Pregnant
  • History of allergy or are sensitive to IC-Green, iodine or to radiographic media
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519219


Contacts
Contact: Kyle Cuneo, MD 734-845-3914 kcuneo@umich.edu
Contact: Jody Sharp (734) 615-4909 sharpjd@umich.edu

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-5010
Contact: Cancer AnswerLine    800-865-1125    canceranswerline@umich.edu   
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Kyle Cuneo, MD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01519219     History of Changes
Other Study ID Numbers: UMCC 2003-081
HUM00041352 ( Other Identifier: University of Michigan Medical IRB )
First Submitted: September 23, 2011
First Posted: January 26, 2012
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by University of Michigan Cancer Center:
hepatic irradiation
IC-GREEN