Health Condition 1: C71- Malignant neoplasm of brain
Conditions
Interventions
Intervention1: Sodium Fluorescein: Used as a dye intra-operatively to visualise the tumor tissue
Dose 5-8mg/kg
Given intravenously during surgical excision
Control Intervention1: Standard surgical res
Sponsors
Department of Neurosurgery
Eligibility
Inclusion criteria
Inclusion criteria: newly diagnosed, untreated suspected high grade glioma and who are eligible for surgery according to the study surgeon
Exclusion criteria
Exclusion criteria: 1. tumours of the midline, basal ganglia, cerebellum, or brain stem as assessed by MRI 2. more than one contrast-enhancing lesion 3. substantial, non-contrast enhancing tumour areas suggesting low-grade glioma with malignant trans formation 4.medical reasons precluding MRI (eg, pacemaker, metallic implants) 5. inability to give consent because of dysphasia or language barrier 6.tumour location did not enable complete resection of contrast-enhancing tumour as decided by individual study surgeon; 7. Karnofsky performance scale 60 or less; 8. renal insufficiency 9.hepatic insufficiency 10.history of malignant tumours at any other body site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with histologically confirmed malignant glioma on neuropathological review without residual contrast-enhancing tumour on postoperative MRI, and progression-free survival at 6 monthsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Residual tumour volume on postoperative MRI 2.Overall survival 3.Type and severity of neurological deficits after surgery 4.Toxic effects Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactAditya Patil
AIIMS Rishikesh
Outcome results
None listed