5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

April 28, 2023 updated by: Sociedad de Lucha Contra el Cáncer del Ecuador
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador
        • Sociedad de Lucha Contra el Cáncer
        • Contact:
        • Principal Investigator:
          • Alberto Valarezo Chuchuca, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

High-Grade Gliomas patients according to the 2021 World Health Organization (WHO) classification at Instituto Oncológico Nacional Dr. Juan Tanca Marengo

Description

Inclusion Criteria:

  • Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
  • Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
  • Patients with high-grade and residual glioma following surgery for gross total resection
  • Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
  • Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
  • Progressing, low-grade infiltrative gliomas with one of the following criteria:
  • Anaplastic foci with contrast uptake in MRI
  • Spectroscopy study in anaplastic suspected area with high malignancy criteria
  • Positive choline PET-CT (positron emission tomography / computer tomography)

Exclusion Criteria:

  • Tumors extending across midline
  • Basal ganglia tumor
  • Brainstem tumor
  • Multifocal gliomas
  • Suspected low-grade glioma without anaplastic foci
  • Neuraxial dissemination (ependymoma)
  • Karnofsky grade less than 60%
  • Infants or pregnant women
  • Acute or chronic types of porphyria
  • Non-acceptance of Fluorescence-Guided Surgery
  • Renal insufficiency confirmed by nephrological assessment
  • Hepatic impairment confirmed by gastroenterological assessment
  • Severe heart disease confirmed by cardiological assessment
  • Decompensated diabetes confirmed by endocrinological assessment
  • Known allergy to any contrast agent and/or previous history of anaphylactic shock
  • Hypersensitivity to the active substance or porphyrins
  • Asthma confirmed by pulmonological assessment
  • Pacemaker use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with known or suspected High-Grade Gliomas
Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Other Names:
  • Gliolan®
  • Gleolan®
Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free-Survival (PFS)
Time Frame: 36 months
Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 36 months
Overall survival is defined as time from initiation to death of any cause
36 months
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire
Time Frame: 36 months
The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.
36 months
Average length of hospital stay (ALOS)
Time Frame: 36 months
The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador

Investigators

  • Principal Investigator: Alberto Valarezo Chuchuca, MD, Sociedad de Lucha Contra el Cáncer del Ecuador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

May 31, 2026

Study Completion (Anticipated)

May 31, 2026

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CISOLGYE20230023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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