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NCT01246869 · ClinicalTrials.gov registry record · Phase 1
Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01246869 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 2 participants.
The verdict
NCT01246869, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO \[World Health Organization\] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (Magnetic resonance imaging) have residual tumor \> 1.0 cm in diameter and will be receiving radiotherapy or (2) newly diagnosed brain metastasis (\> 1.0 cm in diameter who will be receiving radiotherapy. The ability to accurately assess tumor hypoxia and accurately determine the amount/degree of tumor hypoxia could potentially change patient management once validated as tumor hypoxia is known to be associated with a poor prognosis \[Eyler 2008\].
Interventions
- DIAGNOSTIC_TEST Magnetic Resonance Imaging
- DRUG [18F]fluoro-2-deoxy-D-glucose (FDG)
- DRUG 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole
- DRUG [15O]water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-03-27 |
| Est. Completion | 2014-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01246869
The ClinicalTrials.gov registry entry for NCT01246869 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT01246869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01246869 about?
NCT01246869 is a clinical study titled "Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water". Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO \[World Health Organization\] Grade III or IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI (...
What is the current status of trial NCT01246869?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2013-03-27. Estimated completion is 2014-05-03.
What interventions are being tested in trial NCT01246869?
The interventions under investigation include: Magnetic Resonance Imaging (DIAGNOSTIC_TEST), [18F]fluoro-2-deoxy-D-glucose (FDG) (DRUG), 1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole (DRUG), [15O]water (DRUG).
Who is sponsoring clinical trial NCT01246869?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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