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

UnknownOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2021

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Pituitary Adenoma
Interventions
DRUG

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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NX Development Corp

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT04390802 - A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas | Biotech Hunter | Biotech Hunter