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NCT00707343 · ClinicalTrials.gov registry record · Phase 1
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
A Phase 1 study of Cancer and Brain Tumors, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00707343: Completed Phase 1 study of Cancer and Brain Tumors, sponsored by University of Utah.
NCT00707343 is a Phase 1 study of Cancer and Brain Tumors that has completed, run by University of Utah. The registered enrollment target is 15 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00707343, a Phase 1 study of Cancer and Brain Tumors, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many primary brain tumors remain incurable. Most primary brain tumors are highly infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as surgery, focal radiotherapy, radiosurgery or brachytherapy. A particularly problematic aspect of the management of patients with brain tumors is the eventual development of enhancing lesions on MRI after radiation therapy. The treating physician is then left with the dilemma of what this enhancing lesion may represent (radiation necrosis versus recurrent tumor). The differential diagnosis is between recurrent tumor or radiation necrosis however the amount of each contributing to the enhancing mass on MRI is difficult if not impossible to assess. This particular problem is very common and most patients develop some degree of radiation necrosis after therapy with radiation. Differentiation of necrosis from recurrence is particularly challenging. MRI is typically unable to make this important distinction as there is simply an enhancing mass, the etiology of which could be either necrosis or recurrence. Other imaging methods such as FDG-PET have been used but this technique is also complicated in that the normal brain has FDG uptake and it is often difficult to differentiate recurrence from necrosis. \[F-18\]FLT may prove to be the most reliable method in making this important differentiation (necrosis versus recurrence) as normal brain and necrotic brain do not have proliferative activity and thus no \[F-18\]FLT uptake whereas tumor will have proliferative activity and thus \[F-18\]FLT uptake.
Primary Outcome
The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis. Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVm
Conditions Studied
Interventions
- RADIATION FLT-PET Imaging
Study Locations (1)
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-10-31 |
| Est. Completion | 2010-11-30 |
| Phase | Phase 1 |
What the finished NCT00707343 record still lists
NCT00707343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which FLT-PET Imaging is the first listed.
NCT00707343 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT00707343 about?
NCT00707343 is a clinical study titled "[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors". Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many primary brain tumors remain incurable. Most primary brain tumors are highly infiltrative neoplasms, and ar...
What is the current status of trial NCT00707343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2007-10-31. Estimated completion is 2010-11-30.
What conditions does trial NCT00707343 study?
This clinical trial studies the following conditions: Cancer, Brain Tumors.
What interventions are being tested in trial NCT00707343?
The interventions under investigation include: FLT-PET Imaging (RADIATION).
Who is sponsoring clinical trial NCT00707343?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00707343 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00707343's enrollment target sits among peer trials
15 585th of 615 higher than 26 of 615 other Cancer trials
participants (enrollment target), bucketed by value
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