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NCT06160492

5-Aminolevulinic Acid for Photodynamic Diagnosis of Malignant Glioma

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 9 months later, primary endpoint(s) modified, and 1 more.

See at-risk trials from Lee's Pharmaceutical Limited

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 144 → 79 participants Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Primary and study completion dates pushed to Dec 2027
    • Eligibility criteria expanded, about 396 words
    • Interventions modified
    • Trial arms changed: 2 → 1
    • Secondary endpoints: 1 to 7
    • Study description expanded, about 100 words
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 21 words
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Feb 2024 to Apr 14, 2025
    • Study sites: 1 to 2
    • Study title expanded, about 16 words
    • Study description shortened, about 2 words
  3. Eligibility criteria shortened, about 7 wordsv2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Positive Predictive Value
Timeframe: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.

Secondary (7)

Percentage of Participants Without Residual Contrast-Enhancing Tumor on Postoperative MRI
Participant-Level Positive Predictive Value for Fluorescence
Histopathological Positivity Rate in Nonfluorescent Tissue Adjacent to Fluorescent Regions
Negative Predictive Value of Nonfluorescent Tissue Adjacent to Fluorescent Regions
Histopathological Positivity Rate in Nonfluorescent Tissue Distant From the Tumor
Show 2 moreShow less
Negative Predictive Value of Nonfluorescent Tissue Distant From the Tumor
Incidence of Adverse Events

Arms and interventions

5-ALA HCl fluorescence visualizationExperimental

Participants will receive oral 5-ALA HCl 3 hours before anesthesia (range, 2 to 4 hours), followed by surgery with fluorescence visualization of malignant glioma. The protocol specifies 20 mg/kg, with the administered volume selected from the protocol dosing table and a maximum dose of 1.5 g. A single 5-mg intravenous infusion of dexamethasone will be given before oral 5-ALA HCl on the day of surgery. Tissue specimens will be collected for blinded central histopathological assessment. Contrast-enhanced cranial MRI will be performed 24 to 72 hours after surgery.

Drugs: 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution

Sites

2 sites in 1 country