Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00813566 · ClinicalTrials.gov registry record · Phase 1
Multi-Tracer PET Assessment of Primary Brain Tumors
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00813566 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 11 participants.
The verdict
NCT00813566, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide administered for 5 consecutive days every 4 weeks \[Stupp 2005\]. Contrast-enhanced MRI is the current standard for evaluating the success of therapy and monitoring for tumor recurrence. MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy until evidence of recurrence. Despite this careful clinical and radiographic surveillance, and despite decades of research into the histologic and molecular classification of primary brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will result in overall survival times of only months, whereas other histologically-identical gliomas may yield survivals of years to decades \[Carson 2007, Curran 1993, Lamborn 2004\]. Current assessment of tumor response to therapy is also poor. Patients with complete radiographic response after cranial irradiation often progress rapidly post-irradiation. In contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond dramatically to further chemotherapy alone, or the masses may even disappear in the absence of further therapy (so called "tumor pseudoprogression") \[Chamberlain 2007\]. This confounding situation demonstrates a need for better assessment of tumor response.
Interventions
- DRUG [18F]fluoro-2-deoxy-D-glucose (FDG)
- DRUG 3'-deoxy-3'-[18F]fluorothymidine (FLT)
- DRUG [15O]-H2O
- DRUG [11C]Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-11-12 |
| Est. Completion | 2015-02-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00813566
The ClinicalTrials.gov registry entry for NCT00813566 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 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 [18F]fluoro-2-deoxy-D-glucose (FDG) is the first listed.
NCT00813566 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00813566 about?
NCT00813566 is a clinical study titled "Multi-Tracer PET Assessment of Primary Brain Tumors". The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide administered for 5 conse...
What is the current status of trial NCT00813566?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2010-11-12. Estimated completion is 2015-02-03.
What interventions are being tested in trial NCT00813566?
The interventions under investigation include: [18F]fluoro-2-deoxy-D-glucose (FDG) (DRUG), 3'-deoxy-3'-[18F]fluorothymidine (FLT) (DRUG), [15O]-H2O (DRUG), [11C]Acetate (DRUG).
Who is sponsoring clinical trial NCT00813566?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.