Clinical trial · Interventional
ALA-induced PpIX Fluorescence During Brain Tumor Resection
Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection
- 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)
Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.
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 Tumors | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-aminolevulinic acid | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: 5-aminolevulinic acid
- description
- 20mg/kg 3 hours prior to surgery
- interventionNames
- Drug: 5-aminolevulinic acid
Primary outcomes (1)
- measure
- Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
- timeFrame
- Up to five years from the first surgery date
- description
- To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma * Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. * Patient or LAR able to provide written informed consent. * No serious associated psychiatric illnesses. * Age \> 21 years old. Exclusion Criteria: * Pregnant women or women who are breast feeding * History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis. * History of liver disease within the last 12 months. * Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery. * Inability to comply with the photosensitivity precautions associated with the study. * Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
References
Publications (1)
- DERIVEDRoberts DW, Olson JD, Evans LT, Kolste KK, Kanick SC, Fan X, Bravo JJ, Wilson BC, Leblond F, Marois M, Paulsen KD. Red-light excitation of protoporphyrin IX fluorescence for subsurface tumor detection. J Neurosurg. 2018 Jun;128(6):1690-1697. doi: 10.3171/2017.1.JNS162061. Epub 2017 Aug 4. PMID 28777025