Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescein | Drug | — | UNRESOLVED |
| Fluorescein + ALA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fluorescein
- description
- 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.
- interventionNames
- Drug: Fluorescein
- type
- EXPERIMENTAL
- label
- Fluorescein + ALA
- description
- 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.
- interventionNames
- Drug: Fluorescein + ALA
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDRoberts DW, Valdes PA, Harris BT, Hartov A, Fan X, Ji S, Leblond F, Tosteson TD, Wilson BC, Paulsen KD. Glioblastoma multiforme treatment with clinical trials for surgical resection (aminolevulinic acid). Neurosurg Clin N Am. 2012 Jul;23(3):371-7. doi: 10.1016/j.nec.2012.04.001. PMID 22748650
- BACKGROUNDElliott JT, Dsouza AV, Davis SC, Olson JD, Paulsen KD, Roberts DW, Pogue BW. Review of fluorescence guided surgery visualization and overlay techniques. Biomed Opt Express. 2015 Sep 3;6(10):3765-82. doi: 10.1364/BOE.6.003765. eCollection 2015 Oct 1. PMID 26504628
- BACKGROUNDValdes PA, Jacobs V, Harris BT, Wilson BC, Leblond F, Paulsen KD, Roberts DW. Quantitative fluorescence using 5-aminolevulinic acid-induced protoporphyrin IX biomarker as a surgical adjunct in low-grade glioma surgery. J Neurosurg. 2015 Sep;123(3):771-80. doi: 10.3171/2014.12.JNS14391. Epub 2015 Jul 3. PMID 26140489