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5-ALA and FDA approval for glioma surgery | SpringerLink
Source: 202.207.193.112
Article summary:
1. The US Food and Drug Administration (FDA) approved 5-aminolevulinic acid (5-ALA) for use as an intraoperative optical imaging agent in patients with suspected high-grade gliomas (HGGs) in 2017.
2. This approval occurred a decade after European approval and a multicenter, phase III randomized trial which confirmed that surgeons using 5-ALA fluorescence-guided surgery as a surgical adjunct could achieve more complete resections of tumors in HGG patients and better patient outcomes than with conventional microsurgery.
3. The article chronicles the challenges encountered during the US FDA approval process to highlight a new standard for approval of intraoperative optical imaging agents in brain tumors.
Article analysis:
This article is generally reliable and trustworthy, providing an overview of the US Food and Drug Administration's (FDA) approval process for 5-aminolevulinic acid (5-ALA). It provides evidence from a multicenter, phase III randomized trial which confirms that surgeons using 5-ALA fluorescence-guided surgery as a surgical adjunct can achieve more complete resections of tumors in HGG patients and better patient outcomes than with conventional microsurgery. The article also highlights some of the challenges encountered during the FDA approval process, such as its conceptualization as a therapeutic rather than an intraoperative imaging tool.
The article does not appear to be biased or one-sided, presenting both sides equally. It does not contain any promotional content or partiality towards any particular viewpoint or opinion. Possible risks are noted throughout the article, such as potential side effects associated with 5-ALA use. However, there is no mention of any unexplored counterarguments or missing points of consideration regarding the use of 5-ALA for glioma surgery. Additionally, there is no mention of any missing evidence for the claims made throughout the article or any unsupported claims that could potentially undermine its trustworthiness and reliability.