Clinical trial · Interventional
Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma
Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial
- 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)
RATIONALE: Imaging procedures that use aminolevulinic acid (ALA) may help find and diagnose residual tumor in participants with grade IV malignant astrocytoma who are undergoing surgery to remove the tumor. PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of malignant brain tumor through image- guided fluorescence localization. We hypothesize that the use of qualitative fluorescence imaging and point PpIX concentration quantification will enable more complete tumor resection than normal direct (i.e., white light) visualization, and thereby improve participant 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 and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid | Drug | Aminolevulinic Acid | ALIAS |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I: Newly diagnosed GBM 10mg/kg
- description
- Arm I: Newly diagnosed GBM patients receive oral aminolevulinic acid(10mg/kg)at 6 hours before the midpoint of surgery.
- interventionNames
- Drug: aminolevulinic acid
- Procedure: Surgical Resection
- type
- EXPERIMENTAL
- label
- Arm II: Newly diagnosed GBM 20mg/kg
- description
- Arm II: Newly diagnosed GBM patients receive oral aminolevulinic acid (20mg/kg)at 6 hours before the midpoint of surgery.
- interventionNames
- Drug: aminolevulinic acid
- Procedure: Surgical Resection
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor Pathology: Newly diagnosed or recurrent malignant gliomas WHO grade IV * Location: Supratentorial * Resection: Tumor must be judged suitable for resection on the basis of imaging studies. * Consent: Participants must be able to give written, informed consent as approved by the local IRB * Newly Diagnosed Tumors: Participants with newly diagnosed Grade IV glioma who have had not been previously treated with cranial radiation therapy * Recurrent Tumors: Participants with recurrent Grade IV gliomas who have failed cranial radiation therapy Exclusion Criteria: * Pregnant women or those who are breast feeding * Individuals with history of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis * Individuals with history of liver disease in last 12 months * Individuals with AST, ALT, ALP, or bilirubin \>2.5x normal upper limit any time during the previous 2 months * Individuals with plasma creatinine\>180 μmol/L * Individuals who are unable to comply with photosensitivity precautions * Individuals without a grade IV glioma
References
Publications (0)
Data not yet available