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

NCT ID: NCT04390802

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-12-31

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.

Conditions

Pituitary Adenoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

5-aminolevulinic acid

Study participants who are deemed surgical candidates for management of their pituitary lesion will drink 20mg/kg 5-ALA 2-4 hours preoperatively. They will then be taken to the operation room and undergo general anesthesia. Intraoperative blood draw may occur from lines places for anesthesia purposes at any time during the operation. In alignment with the neurosurgeon's practice and discretion, the sella will be accessed and opened. During the surgical exploration of the sella, the surgeon will attempt to identify the pituitary mass. The location of the tumor will be assessed using the blue-light filtered microscope or endoscope. These steps will be documented photographically during the operation. A biopsy of the fluorescent region will be taken to confirm pituitary adenoma histopathology. The tumor will then be maximally resected. The tumor sample will be used for further clinical testing as part of the patient's routine care.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NX Development Corp

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pamela Stuart Jones

Assistant Professor of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2019P003509

Identifier Type: -

Identifier Source: org_study_id