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NCT Number: NCT02155452

Fluorescence and Glioma Heterogeneity

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.

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Key information

Conditions

Malignant Gliomas Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Centre for Treatment, Research & Education in Cancer (ACTREC)

Navi Mumbai, Maharashtra, 410210, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALA

Procedure

Prior to surgery all patients would receive freshly prepared solution of 5-ALA, 20 mg/kg bodyweight dissolved in 100 ml of potable water orally approximately 4 hours (range 4-6 hrs) before the commencement of anesthesia induction for surgery.

The surgery would then be performed with the help of navigation. After craniotomy, the navigation software would be used to identify the selected target areas based on the preoperative images (MR as well as PET when available) and directed image-guided biopsies from these representative areas will be collected for histological evaluation

Other names: 5- ALA

Primary outcomes

  1. Degree of fluorescence

    Time frame: At the time of surgery within 72 hours

    • Degree of fluorescence in different tumor regions
    • PPIX Qualification

Secondary outcomes

  1. High throughput proteomic screening of tissue samples

    Time frame: Postoperatively within 1 week of the excision

    -A quantitative approach will be undertaken to compare the proteome profile

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

Understanding the Mechanisms of ALA-induced Fluorescence in Malignant Gliomas - Exploring the Biological Basis of Tumoral Heterogeneity.

Acronym: ALAglioma

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2014
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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