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

NCT04390802 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-02-24

No results posted yet for this study

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

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

  • NX Development Corp

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390802 on ClinicalTrials.gov