A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas

• Conditions: Pituitary Adenoma

• Registration Number: NCT04390802
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24
• Study Start: 2021-07
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with intraoperative observed fluorescence of pituitary tumor	through study completion, an average of 3 months	Under blue light exposure of tumor, the investigators will document whether red fluorescence is seen (+ fluorescence) or not seen (- fluorescence). These will be categorized as a binary finding. If fluorescence is seen, the surgeon will biopsy this area to confirm that fluorescent tissue is consistent with pituitary adenoma by histopathology.

Secondary Outcome Measures

Name	Time	Method
Differences in presence of fluorescence based on hormone receptor staining of the pituitary adenoma	through study completion, an average of 3 months	If possible, the investigators will report differences in presence and degree of fluorescence between different types of pituitary adenomas based on their hormone receptor staining status by immunohistochemistry.