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NCT02966223 · ClinicalTrials.gov registry record · NA

A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver

A NA study, sponsored by Indiana University.

Terminated
Registry status
NA
Development phase
20
Enrollment target

NCT02966223 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 20 participants.

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The verdict

NCT02966223, a NA study, was terminated before completion, sponsored by Indiana University.

TERMINATED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

The primary question of interest is quantifying the relationship between Y-90 liver therapy and liver damage. Little is known on this subject. Present assumptions and calculations of Y-90 administration are based on surgical lobar hepatectomies and external radiation beam therapies. The investigators hope that by using a functional model of the liver, the investigators can improve this important knowledge gap. The investigators will be enrolling patients planning to receive Y-90 therapy for the treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of the present diagnostic model and the significant risk of biopsy and tumor seeding. Y-90 therapy involves administering radioactive particles to liver tumors by placing a catheter in a hepatic artery supplying the tumor using angiographic techniques and injection of these particles. Y-90 Positron Emission Tomography-Computed Tomography (PET/CT) imaging has been established as a method to validate and quantitate distribution of Yttrium after Y-90 administration. The post Y-90 therapy PET/CT images provide an imaging distribution of the Y-90, which is essential for validation of administered versus planned dose to the liver lesion and background liver. If the investigators can compare the Y-90 distribution to estimate background liver radiation distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and regional function map (generated by the hepatobiliary \[HIDA\] scan performed before and after therapy), then the investigators will be assuming that the difference pre and post therapy in global and regional function can be ascribed to the Y-90 administration. The investigators will also analyze the Magnetic Resonance Imaging (MRI) and CT sets performed before and after therapy

Interventions

  • RADIATION MRI and HIDA scan

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-08-17
Est. Completion 2020-04-24
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT02966223

The ClinicalTrials.gov registry entry for NCT02966223 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which MRI and HIDA scan is the first listed.

NCT02966223 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02966223 about?

NCT02966223 is a clinical study titled "A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver". The primary question of interest is quantifying the relationship between Y-90 liver therapy and liver damage. Little is known on this subject. Present assumptions and calculations of Y-90 administration are based on surgical lobar hepatectomies and external radiation beam therapies. The investigator...

What is the current status of trial NCT02966223?

This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2017-08-17. Estimated completion is 2020-04-24.

What interventions are being tested in trial NCT02966223?

The interventions under investigation include: MRI and HIDA scan (RADIATION).

Who is sponsoring clinical trial NCT02966223?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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