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Trial record 6 of 807 for:    ALA

Fluorescence and Glioma Heterogeneity (ALA glioma)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Tata Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Dr Aliasgar V Moiyadi, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02155452
First received: May 17, 2014
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Malignant Gliomas
Procedure: ALA Test group

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Understanding the Mechanisms of ALA-induced Fluorescence in Malignant Gliomas - Exploring the Biological Basis of Tumoral Heterogeneity.

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Degree of fluorescence [ Time Frame: At the time of surgery within 72 hours ] [ Designated as safety issue: No ]
    1. Degree of fluorescence in different tumor regions
    2. PPIX Qualification


Secondary Outcome Measures:
  • High throughput proteomic screening of tissue samples [ Time Frame: Postoperatively within 1 week of the excision ] [ Designated as safety issue: No ]
    -


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 25
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
With ALA
Patients with malignant glioma. 25 patients will be provided the ALA for inducing fluorescence
Procedure: ALA Test group

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

Without ALA
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with malignant glioma

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02155452

Contacts
Contact: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery) 91-22-27405000 ext 5076 aliasgar.moiyadi@gmail.com

Locations
India
Advanced Centre for Treatment, Research & Education in Cancer (ACTREC) Recruiting
Navi Mumbai, Maharashtra, India, 410210
Contact: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery)    91-22-27405000 ext 5076    aliasgar.moiyadi@gmail.com   
Principal Investigator: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery)         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery) Prof Neurosurgery
Principal Investigator: Aliasgar V Moiyadi, Prof Neurosurgery The Medicines Company
  More Information

No publications provided

Responsible Party: Dr Aliasgar V Moiyadi, Prof Neurosurgery, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02155452     History of Changes
Other Study ID Numbers: TMC- ACTREC IRB project no 139
Study First Received: May 17, 2014
Last Updated: June 3, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Tata Memorial Hospital:
ALA
Malignant gliomas

Additional relevant MeSH terms:
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on February 27, 2015