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NCT01128218 · ClinicalTrials.gov registry record · Phase 1
A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors
A Phase 1 study, sponsored by Southern Illinois University.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01128218 is a Phase 1 study that has completed, run by Southern Illinois University. The registered enrollment target is 33 participants.
The verdict
NCT01128218, a Phase 1 study, has completed, sponsored by Southern Illinois University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
Extent of resection is a very important prognostic factor affecting survival in individuals diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma tumor cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts at total resection. The investigators propose to identify the borders of malignant gliomas intraoperatively using oral 5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and thereby provide an opportunity for more complete tumor resection. When exogenous 5-ALA is provided at increased concentration the tumor cells will become fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively and facilitates complete resection. Data collection will include measurement of dose-limiting toxicity, tumor fluorescence, and tumor density. Data analysis will evaluate toxicity, sensitivity, and specificity of 5-ALA. Following completion of the phase 1 portion of this trial, an additional 14 subjects will be entered at the recommended phase 2 dose level in order to further define the above parameters at the recommended phase 2 dose level.
Interventions
- DRUG Tumor fluorescence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-03 |
| Est. Completion | 2021-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128218
The ClinicalTrials.gov registry entry for NCT01128218 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern Illinois University, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tumor fluorescence is the first listed.
NCT01128218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128218 about?
NCT01128218 is a clinical study titled "A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors". Extent of resection is a very important prognostic factor affecting survival in individuals diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma tumor cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tu...
What is the current status of trial NCT01128218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-03. Estimated completion is 2021-02.
What interventions are being tested in trial NCT01128218?
The interventions under investigation include: Tumor fluorescence (DRUG).
Who is sponsoring clinical trial NCT01128218?
This trial is sponsored by Southern Illinois University, which has 21 total clinical trials registered on ClinicalTrials.gov.
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