RECRUITINGPhase 2INTERVENTIONAL
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology
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 first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form by subject or subject's LAR.
4. No serious associated psychiatric illnesses.
5. Age ≥ 21 years old.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Fluorescein
DRUG
Fluorescein + ALA
Locations (1)
Sally B Mansur
Lebanon, New Hampshire, United States