This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.
This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The exogenous application of ALA leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (λ = 375 - 440 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light. This phenomenon allows for the real-time visualization of tumor tissue during resection surgery. Patients about to undergo resection for suspected meningioma \[World Health Organization (WHO) Grade I, II, III\] will be screened and informed consent will be obtained prior to surgery and prior to study participation. Eligible study participants will receive an oral solution of Gleolan (20 mg/kg body weight) 3 hours, (target range 2-4 hours) prior to anesthesia, and then undergo surgery for meningioma resection. During the surgery, the surgeon will use a microscope equipped with WL and BL for visualization of Gleolan-induced PpIX fluorescence for the selection of protocol-driven tissue locations and to assess fluorescence status. Study participants will be evaluated within 48 hours post procedure, 2 weeks post procedure, and 6 weeks post procedure for study safety assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
108
One time oral dose on day of surgery (20 mg/kg bodyweight)
Mayo Clinic
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
The proportion of participants who have at least one indeterminate tissue or unexpected fluorescent End of Surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status is consistent with histology.
Per Protocol Population
Time frame: Surgery (Day 1)
Positive Predicted Value (PPV) of Gleolan-induced PpIX fluorescence of the single bulk tumor tissue obtained from each study participant
Per Protocol Population
Time frame: Surgery (Day 1)
Diagnostic accuracy of Gleolan-induced PpIX fluorescence among indeterminate tissue and unexpected fluorescent EOS tissue locations is at least 20% greater than the diagnostic accuracy of the surgeons' assessment.
Biopsy Efficacy Analysis Population
Time frame: Surgery (Day 1)
Diagnostic performance of Gleolan-induced PpIX fluorescence will be computed for indeterminate tissue biopsies, unexpected fluorescent EOS tissue biopsies.
Biopsy Efficacy Analysis Population
Time frame: Surgery (Day 1)
The concordance between the Surgeon and Adjudication Panel assessment of white light (WL) visualization visualization to identify tissue as likely or unlikely to be meningioma among indeterminate tissues.
Biopsy Efficacy Analysis Population
Time frame: Surgery (Day 1)
The concordance between the Surgeon and Adjudication Panel assessment of blue light (BL) visualization to identify fluorescence status of indeterminate tissues.
Biopsy Efficacy Analysis Population
Time frame: Surgery (Day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Keck Hospital of USC
Los Angeles, California, United States
Providence St. Joseph Hospital
Orange, California, United States
Swedish Medical Center
Englewood, Colorado, United States
University of Miami
Coral Gables, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Southern Illinois University
Springfield, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
...and 7 more locations