Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology
Who is this study for? Adult patients with Brain Cancer
What treatments are being studied? Fluorescein
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
• Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
• Valid informed consent by subject or subject's LAR.
• No serious associated psychiatric illnesses.
• Age ≥ 21 years old.
Locations
United States
New Hampshire
Sally B Mansur
RECRUITING
Lebanon
Contact Information
Primary
Sally B Mansur, MS
Sally.B.Mansur@Dartmouth.edu
Backup
Keith D Paulsen, PhD
Keith.D.Paulsen@Dartmouth.edu
Time Frame
Start Date:2016-03
Estimated Completion Date:2026-12
Participants
Target number of participants:30
Treatments
Active_comparator: Fluorescein
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure.
Experimental: Fluorescein + ALA
Fluorescein administered IV at 5mg/kg approximately 30 minutes prior to the beginning of the tumor resection. A second injection may occur if the fluorescein fluorescence is dissipated substantially during the course of the procedure.~ALA administered orally at 20mg/kg approximately 3 hours before surgery.