Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
Recruiting
Phase 2
Interventional Study
Brain Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 30 (estimated)
- Sponsor
- David W. Roberts · Other
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About This Trial
This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure.
Subjects will include those people with operable brain tumor with fir…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
2. Tumor judged to be suitable for open cranial resection based on preoperative imagin…
Contacts