Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

May 16, 2024 updated by: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid

This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

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

  • China
      • Shanghai, China
        • Huashan Hospital, Fudan University
        • Contact:
          • jingsong wu, Doctor

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

Description

Inclusion Criteria:

  • Patient's written informed consent
  • Age 18-75 years
  • Radiological suspicion of a malignant glioma
  • Indication for surgical tumour resection
  • Karnofsky Performance Status (KPS) ≥ 70

Exclusion Criteria:

  • Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
  • Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
  • known hypersensitivity to the test drug ingredients
  • Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 Aminolevulinic Acid
This is an single arm study.
Drug: 5 Aminolevulinic Acid
3±1 hours before anesthesia, participants will take 5-ALA orally at a dosage of 20 mg/kg, followed by fluorescence-guided resection of malignant glioma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
Time Frame: within 48h after surgery
The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas.
within 48h after surgery

Collaborators and Investigators

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

Sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F0009-01

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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