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Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatic Irradiation

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Trial Information

Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Baseline IC-GREEN elimination

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Mary Feng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2003-081

NCT ID:

NCT01519219

Start Date:

January 2003

Completion Date:

January 2016

Related Keywords:

  • Hepatic Irradiation
  • hepatic irradiation
  • IC-GREEN

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752