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NCT04462419 · ClinicalTrials.gov registry record
18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
A clinical trial, sponsored by Mayo Clinic.
- Terminated
- Registry status
- 19
- Enrollment target
NCT04462419: Clinical Trial study, sponsored by Mayo Clinic.
NCT04462419 is a clinical trial that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04462419 was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
Study Summary
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.
Primary Outcome
Will be estimated to delineate tumor progression from radionecrosis for use in future studies. The optimal TBRmax and TBRmean thresholds will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%.
Interventions
- OTHER Fluciclovine F18
- RADIATION Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2024-11-13 |
Why NCT04462419 stopped before completion
NCT04462419 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Fluciclovine F18 is the first listed.
NCT04462419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04462419 about?
NCT04462419 is a clinical study titled "18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain". This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in ...
What is the current status of trial NCT04462419?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2020-08-18. Estimated completion is 2024-11-13.
What interventions are being tested in trial NCT04462419?
The interventions under investigation include: Fluciclovine F18 (OTHER), Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography (RADIATION).
Who is sponsoring clinical trial NCT04462419?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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