Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

Conditions

• Brain Cancer

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorescein — DRUG
• Fluorescein + ALA — DRUG

Study Details

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.

Key Dates

Start date

Mar 31, 2016

Status verified

Jul 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• 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.

Primary Outcome Measure

Fluorescein performance as an intraoperative biomarker for tumor tissue will be reported. [ Time Frame: 24 months ]

Central Contacts

• Sally B Mansur, MS
  [email protected]
• Keith D Paulsen, PhD
  [email protected]

Locations (1)

Find similar trials in Lebanon, NH

Related Studies

• HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)
  Recruiting · Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire
• Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors
  Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York
• Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
  PHASE2 · Recruiting · Northwell Health · New York, New York
• Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
  PHASE1/PHASE2 · Recruiting · Northwell Health · New York, New York