Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT01502605
Eligibility Criteria:
Inclusion Criteria:
* Patients must have clinically documented primary brain tumor for which resection is clinically indicated. Radiographic findings should be consistent with high grade glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
* Patients must be aged greater than 18 years old
* Karnofsky Performance Score \> 70 (Appendix)
* Patients must have normal organ and marrow function as defined below:
* Leukocytes \> 3,000 /uL
* Absolute neutrophil count \> 1,500/uL
* Platelets \> 100,000/uL
* Total bilirubin within normal institutional limits
* AST/ALT within normal institutional limits
* Creatinine within normal institutional limits
Exclusion Criteria:
* Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
* History of allergic reactions to compounds of similar chemical composition to ALA.
* Personal or family history of porphyrias
* Personal history of hepatitis or other liver diseases.
* Pregnant women are excluded from this study because ALA is of unknown teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued prior to treatment with ALA.
* Inability to undergo magnetic resonance imaging (i.e. those patients with AICD/pacemakers).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01502605
Study Brief:
Protocol Section:
NCT01502605