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NCT01519219 · ClinicalTrials.gov registry record

Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation

A clinical trial, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
208
Enrollment target

NCT01519219: Completed study, sponsored by University of Michigan Rogel Cancer Center.

NCT01519219 is a clinical trial that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 208 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01519219 has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
208 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • RADIATION Hepatic Irradiation

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2004-11-24
Est. Completion 2020-02-19

What the finished NCT01519219 record still lists

NCT01519219 is an observational study that tracks outcomes without assigning an intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Hepatic Irradiation is the first listed.

NCT01519219 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01519219 about?

NCT01519219 is a clinical study titled "Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation". 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 provi...

What is the current status of trial NCT01519219?

This trial is currently completed. The enrollment target is 208 participants. The study started on 2004-11-24. Estimated completion is 2020-02-19.

What interventions are being tested in trial NCT01519219?

The interventions under investigation include: Hepatic Irradiation (RADIATION).

Who is sponsoring clinical trial NCT01519219?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01519219, the US trial registry maintained by the National Library of Medicine. NCT01519219 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.