Article
5-ALA for fluorescence-guided resections of newly diagnosed or recurrent meningiomas – the NXDC-MEN-301 study
Verwendung von 5-ALA für die fluoreszenzgestützten Resektion von neu Diagnostizierten und rezidivierten Meningeomen – die NXDC-MEN-301 Studie
Search Medline for
Authors
-
Eric Suero-Molina
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland
-
Bernarnd Bendok
- Mayo Clinic, Department of Neurosurgery, Phoenix, AZ, Vereinigte Staaten
-
Michael Vogelbaum
- Moffit Cancer Center, Tampa, FL, Vereinigte Staaten
-
Ashley Cox
- NX Development Corp., Lexington, KY, Vereinigte Staaten
-
Joe Wyse
- NX Development Corp., Lexington, KY, Vereinigte Staaten
-
Murray Sackmann
- NX Development Corp., Lexington, KY, Vereinigte Staaten
-
Alan Ezrin
- NX Development Corp., Lexington, KY, Vereinigte Staaten
-
Walter Stummer
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland
| Published: | May 25, 2022 |
|---|
Outline
Text
Objective: 5-aminolevulinic acid (5-ALA; Gliolan®) is approved for fluorescence-guided resections of suspected malignant gliomas. Past experience has demonstrated that meningiomas also show fluorescence, which may be a useful surgical adjunct. We present the design of a multi-center, prospective study to determine clinical safety and benefit of fluorescence-guided resections of meningiomas.
Methods: All patients with suspected, meningioma (all grades) receive Gleolan 20mg/kg 2-4 hours prior to surgery performed supported by fluorescence excitation from a blue light source (Blue400, FL400). Surgeons are asked whether residual tumor can be observed to fluoresce under blue light after the tumor is no longer recognizable using conventional illumination at the end of surgery. Endpoints include defining the percentage of the patients with additional residual tumor, the diagnostic accuracy of fluorescence after maximal resection under white light versus correlative histology, and to assess potential improvements in tumor detection and decision making versus correlative histology. Thus, this study not only investigates how often surgeons discover unexpected fluorescent residual tumor, but also when fluorescence in indeterminate tissue might influence decision making. All surgical videos are reviewed by an independent review committee blinded to surgeons’ assessment of tissue type and fluorescence status. Clinical chemistry, hematology, protocol adherence and procedural safety are evaluated over a 6-week post-surgery time period. Data will be included from approximately 100 study participants completing the study at approximately 15 centers in the United States, Germany and Austria.
Results: As of January 2022, 55 patients have completed the study. No adverse safety signal has been detected.
Conclusion: Preliminary data from 55 meningioma patients indicate Giolan can be used safely for fluorescence-guided resection of meningiomas and confirms feasibility of our study design. Accrual is targeted for completion in the middle of 2022.
