Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center; David W. Roberts
• Collaborators: Carl Zeiss Meditec, Inc.; National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Aminolevulinic Acid

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 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, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.

4. History of liver disease within the last 12 months.

5. Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery.

6. Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.

7. Inability to comply with the photosensitivity precautions associated with the study.