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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850377
• Other study ID #: CISOLGYE20230023
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2023
• Source: Sociedad de Lucha Contra el Cáncer del Ecuador
• Contact: Alberto Valarezo Chuchuca, MD
• Phone: +593 998 686 027
• Email: valarezoalb[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Neoplasms, Adult, Malignant
• Brain Tumor
• Central Nervous System Neoplasms
• Dermatitis, Phototoxic
• Glioma
• Glioma, Malignant
• High Grade Glioma
• Neoplasm Malignant
• Neoplasm, Residual
• Neoplasms
• Neoplasms, Neuroepithelial
• Nervous System Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Photosensitizing Agents

Intervention

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.

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.

Locations

Country	Name	City	State
Ecuador	Sociedad de Lucha Contra el Cáncer	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad de Lucha Contra el Cáncer del Ecuador

Country where clinical trial is conducted

Ecuador, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free-Survival (PFS)	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	Overall survival (OS)	Overall survival is defined as time from initiation to death of any cause	36 months
Secondary	Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire	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
Secondary	Average length of hospital stay (ALOS)	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