A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas
A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas
5-Aminolevulinic Acid (5-ALA) was approved by the FDA as an intraoperative optical imaging
 agent in patients with suspected high-grade gliomas (HGGs) in 2017. The investigators plan to
 administer 5-ALA to patients with pituitary tumors to demonstrate whether it can be used as
 an intraoperative optical imaging agent for this pathology. Overall, this pilot study will
 afford the overall opportunity to improve surgical management and advancement of the science
 of neurological and neuroendocrine disease.
Inclusion Criteria:

 -  Patients with non-functioning pituitary adenomas who require surgical intervention, as
 deemed appropriate by a neurosurgeon, either due to size criteria, observed growth in
 lesion on MRI, and/or for alleviation of the symptoms of mass effect.

 -  Patients with functional pituitary adenomas, including prolactinomas, growth-hormone
 secreting adenomas, and ACTH-secreting adenomas, where surgery is recommended for
 biochemical control. Patients with symptoms of Cushing's Disease and centralization of
 ACTH on IPSS without imaging-confirmed lesions will be included in the study.

 Exclusion Criteria:

 -  History of allergic reactions attributed to compounds of similar chemical or biologic
 composition to aminolevulinic acid (ALA). Patients should refrain from use of other
 potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones,
 hypericin extracts) for 72 hours.

 -  Personal or family history of porphyria.

 -  Uncontrolled concurrent illness including, but not limited to ongoing or active
 infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
 arrhythmia, or psychiatric illness/social situations that would limit compliance with
 study requirements. Because there is an unknown but potential risk for adverse events
 in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding
 should be discontinued if the mother is treated with 5-aminolevulinic acid.

 -  Women who are pregnant or become pregnant will be excluded from the trial as it is
 unknown if aminolevulinic acid (ALA) is teratogenic or has abortifacient effects.

 -  Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.