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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: Clinical Trial NA study, sponsored by Indiana University.
NCT02966223 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Difference in regional liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.
Interventions
- RADIATION MRI and HIDA scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2020-04-24 |
| Phase | NA |
Why NCT02966223 stopped before completion
NCT02966223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which MRI and HIDA scan is the first listed.
NCT02966223 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02966223's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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