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NCT04044937 · ClinicalTrials.gov registry record · Phase 2
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
A Phase 2 study, sponsored by Thomas Hope.
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT04044937: Completed Phase 2 study, sponsored by Thomas Hope.
NCT04044937 is a Phase 2 study that has completed, run by Thomas Hope. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044937, a Phase 2 study, has completed, sponsored by Thomas Hope.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
Primary Outcome
Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = \[TP / (TP + FN)\] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence
Interventions
- PROCEDURE Positron Emission Tomography (PET)
- DRUG F-18 Fluoroethyltyrosine (FET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 2 |
What the finished NCT04044937 record still lists
NCT04044937 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Positron Emission Tomography (PET) is the first listed.
NCT04044937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04044937 about?
NCT04044937 is a clinical study titled "Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms". This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize th...
What is the current status of trial NCT04044937?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2018-10-29. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT04044937?
The interventions under investigation include: Positron Emission Tomography (PET) (PROCEDURE), F-18 Fluoroethyltyrosine (FET) (DRUG).
Who is sponsoring clinical trial NCT04044937?
This trial is sponsored by Thomas Hope, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04044937's enrollment target sits among peer trials
143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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