Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology
David W. Roberts
Summary
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 first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
Description
Consenting subjects who have met inclusion and exclusion criteria will be enrolled to receive either fluorescein+ALA or fluorescein alone. HGG patients will be randomized on a 2 to 1 basis to receive either both fluorescein and ALA or fluorescein alone, and LGG patients will be randomized on a 1 to 1 basis. This study is a diagnostic trial of fluorescein fluorescence as an intraoperative imaging biomarker during open cranial surgery for tumor resection of first-time (preoperatively) presumed high or low grade glioma. Subjects participate in a "one-time" event/visit (i.e, surgery) as part of t…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 imaging studies. 3. Valid informed consent by subject or subject's LAR. 4. No serious associated psychiatric illnesses. 5. Age ≥ 21 years old. Exclusion Criteria: 1. Pregnant women or women who are breast feeding. 2. History of hypersensitivity to fluorescein. 3. History of cutaneous photosensitivity, p…
Interventions
- DrugFluorescein
- DrugFluorescein + ALA
Location
- Sally B MansurLebanon, New Hampshire