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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: Completed Phase 1 study, sponsored by University of Utah.

NCT00813566 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 11 participants
Start Date 2010-11-12
Est. Completion 2015-02-03
Phase Phase 1
University of Utah

818 total trials

What the finished NCT00813566 record still lists

NCT00813566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 4 interventions - of which [18F]fluoro-2-deoxy-D-glucose (FDG) is the first listed.

NCT00813566 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00813566's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00813566, the US trial registry maintained by the National Library of Medicine. NCT00813566 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.