Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Southern Illinois University.
NCT01128218 is a Phase 1 study that has completed, run by Southern Illinois University. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose escalation from 10mg/kg to 50mg/kg to determine optimal 5-ALA dose
Interventions
- DRUG Tumor fluorescence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-03 |
| Est. Completion | 2021-02 |
| Phase | Phase 1 |
What the finished NCT01128218 record still lists
NCT01128218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Tumor fluorescence is the first listed.
NCT01128218 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01128218's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02861898 · 33 participants · Phase 1
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
- NCT04871607 · 33 participants · Phase 2
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
- NCT05071937 · 33 participants · Phase 2
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
- NCT05168618 · 33 participants · Phase 2
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia