Fluorescence and Glioma Heterogeneity

NCT02155452 | Completed DMC

• 1 other identifier: TMC- ACTREC IRB project no 139
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Gliomas

Keywords

ALA; Malignant gliomas

Outcome Measures

Primary Outcomes (1)

• Degree of fluorescence

  1. Degree of fluorescence in different tumor regions 2. PPIX Qualification

  At the time of surgery within 72 hours

Secondary Outcomes (1)

• High throughput proteomic screening of tissue samples

  Postoperatively within 1 week of the excision

Study Arms (2)

With ALA

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

Procedure: ALA

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

Interventions

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

Also known as: 5- ALA

With ALA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant glioma

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

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

Navi Mumbai, Maharashtra, 410210, India

Location

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.

MeSH Terms

Conditions

Glioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Aliasgar V Moiyadi, MCh DNB

  neurosurgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Neurosurgery

Study Record Dates

• First Submitted: May 17, 2014
• First Posted: June 4, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

IN (1)