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NCT01105988 · ClinicalTrials.gov registry record · Early Phase 1
Evaluating Tumor Pseudoprogression With FLT-PET and MRI
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT01105988: Clinical Trial Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01105988 is a Early Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01105988, a Early Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation or tumor growth and worsening of disease. Currently the only way to definitively distinguish inflammation from tumor growth is biopsy. However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive method to distinguish post-treatment inflammation from tumor growth can help improve care for patients with glioma. For the PET scans in this research study, the investigators are using a radioactive substance called FLT (3'-deoxy-3'-\[F-18\] fluorothymidine), instead of the standard substance FDG (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation. Because of that FLT may be better than FDG in differentiating cancer cells from inflammation. An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this research study. The two MRI scans performed will also help give more information about the patient's tumor that is not routinely provided with a routine clinical scan, such as blood flow through the tumor or metabolic activity in the tumor. The information from these special MRI scans may provide more information about the blood supply to the tumor and how this changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may help how to distinguish inflammation due to radiation therapy from tumor growth.
Primary Outcome
To determine if elevated FLT PET uptake 4 weeks after completion of chemoradiation is associated with early tumor growth rather than treatment effect in patients with newly diagnosed glioblastome treated with standard chemoradiation.
Interventions
- OTHER Radiologic exams
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-10 |
| Phase | Early Phase 1 |
Why NCT01105988 stopped before completion
NCT01105988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Radiologic exams is the first listed.
NCT01105988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01105988 about?
NCT01105988 is a clinical study titled "Evaluating Tumor Pseudoprogression With FLT-PET and MRI". A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if t...
What is the current status of trial NCT01105988?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2011-05. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01105988?
The interventions under investigation include: Radiologic exams (OTHER).
Who is sponsoring clinical trial NCT01105988?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01105988's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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