NCT02691923 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Elliott JT, Dsouza AV, Davis SC, Olson JD, Paulsen KD, Roberts DW, Pogue BW
Review of fluorescence guided surgery visualization and overlay techniques. Biomed Opt Express. 2015 Sep 3;6(10):3765-82. doi: 10.1364/BOE.6.003765. eCollection 2015 Oct 1.
Roberts DW, Valdes PA, Harris BT, Hartov A, Fan X, Ji S, Leblond F, Tosteson TD, Wilson BC, Paulsen KD
Glioblastoma multiforme treatment with clinical trials for surgical resection (aminolevulinic acid). Neurosurg Clin N Am. 2012 Jul;23(3):371-7. doi: 10.1016/j.nec.2012.04.001.
Valdes PA, Jacobs V, Harris BT, Wilson BC, Leblond F, Paulsen KD, Roberts DW
Quantitative fluorescence using 5-aminolevulinic acid-induced protoporphyrin IX biomarker as a surgical adjunct in low-grade glioma surgery. J Neurosurg. 2015 Sep;123(3):771-80. doi: 10.3171/2014.12.JNS14391. Epub 2015 Jul 3.

Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology

Details for clinical trial NCT02691923

Clinical trial NCT02691923 - References