Fluorescence and Glioma Heterogeneity (ALAglioma)

Tata Memorial Hospital

Status: Completed

Conditions: Malignant Gliomas

Treatments: Procedure: ALA

Study type: Observational

Funder types: Other

Identifiers

NCT02155452

TMC- ACTREC IRB project no 139

Details and patient eligibility

About

The investigators aim to study the heterogeneity of fluorescence within malignant gliomas by sampling tissues from these variable areas within the same tumor. These tissue samples will then be subjected to pathological and biological analysis to assess proteins related to ALA metabolism and correlated with the fluorescence emitted as well as levels of protoporphyrin IX in the tissues.

Full description

Malignant gliomas are the commonest malignant brain tumors but are extremely challenging to treat. Neuro-oncology has seen little progress in its treatment despite extensive research. Extent of resection remains a very important prognostic factor in these tumors. Better the resection, better the outcomes. However resecting these tumors is not very easy primarily due to their infiltrative nature and difficulty in discerning tumor boundaries intraoperatively. Fluorescence guided resection (FGR) has recently been shown to be a very important and useful adjunct in maximizing this goal. FGR involves administration of aminolevulinic acid (ALA) to the patient prior to surgery. The ALA is converted to protoporphyrin IX (PPIX) in glioma cells. The PPIX is a fluorophore and can be visualized intraoperatively using a suitably modified microscope. Neurosurgeons can then resect the tumor radically guided by this fluorescence which is superior to the conventional microscopic resection. Selective PPIX accumulation in glioma cells is the key to the accuracy of this technique. The biological basis of selectivity of PPIX accumulation within glioma cells is however poorly understood. Various mechanisms could be involved starting from variable transport (related to blood-brain barrier properties), differential uptake (governed by active transport mechanisms) and differential metabolism within the cell. Understanding these mechanisms can lead to refinements in this strategy, overcoming its present limitations and development of methods to extend its scope.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Per-primum glioma

• Adults (18-65 years)
• Radiologically suspected malignant gliomas
• Variable contrast enhancement on MRI (patchy and/or non-uniform)
• Eligible for surgical therapy (craniotomy NOT stereotactic biopsy )
• No contraindication for surgery

Exclusion criteria

• Poor general condition (KPS < 70)
• Prior treatment (except biopsy)
• Compromised renal/hepatic function
• Immunocompromised status
• Known photosensitivity / allergy to 5-ALA

Trial design

25 participants in 2 patient groups

With ALA

Description:

Patients with malignant glioma. 25 patients will be provided the ALA for inducing fluorescence

Treatment:

Procedure: ALA

Without ALA

Description:

5 tumor tissue samples from ACTREC tumor tissue repository will be obtained. These would be malignant gliomas or other brain tumor samples where ALA is usually not administered and will be used as controls and for calibration purposes