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.

Study Overview

• Status: Unknown
• Conditions: Pituitary Adenoma
• Intervention / Treatment: Drug: 5-aminolevulinic acid

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will study patients with pituitary macroadenomas 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. The investigators will also study patients with functional pituitary adenomas, including prolactinomas, growth-hormone secreting adenomas, and ACTH-secreting adenomas, where surgery is recommended for biochemical control.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with intraoperative observed fluorescence of pituitary tumor	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.	through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in presence of fluorescence based on hormone receptor staining of the pituitary adenoma	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.	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: NX Development Corp

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (ACTUAL): May 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 2019P003509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No