An observational study in Indocyanine Green and Skull Base Neoplasms, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by University of California, San Francisco · Observational
Endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves (ON). Surgery often involves dissecting tumors from the optic nerves and its blood supply, which can result in nerve damage and visual loss after surgery. To date, there are no reliable methods to monitor the optic nerve function during surgery and thus, post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam. This delay in diagnosis prevents early therapeutic measures and can result in further harm to the ON. We have recently recognized that when ICG is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying (SHA) the ON are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery. Thus, ICG may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap. This study will assess whether endoscopic ICG angiography before and after resection of suprasellar lesions can predict post-operative visual deficits. Successful completion will provide surgeons a novel tool to assess visual function during surgery. The ICG endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries.
20 studies on the registry are indexed under Skull Base Neoplasms; 7 are open to participants now.
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Participants diagnosed in the clinic with sellar or suprasellar pituitary tumors and scheduled for an endoscopic endonasal surgical resection will be approached to obtain consent to participate in this study. These patients will be identified by the PI of this study who will recommended the use of ICG based in the tumor characteristics and risk-benefit potential for the patient.
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Exclusion Criteria:
Eligible participants are those diagnosed with suprasellar lesions undergoing ICG angiography during endoscopic endonasal resection.
Procedure: Indocyanine Green
Tumor resection, direct visualization of the chiasm and both optic nerves and ICG administration will be provided as it is recommended by the standard of care. ICG will be administered by an injection of 5 mg of ICG diluted in a 10 mL syringe performed in the line closest to the heart followed by a 10-mL saline bolus. Using near-infrared lighting, the investigators will determine the time between anterior cerebral arteries (ACA) peak luminescence to the peak luminescence of the superior hypophyseal arteries enveloping the optic chiasm (ACA to chiasm time). Because luminescence of large vessels precedes small arterial penetration, signal from the ACAs was considered as "time 0" to account for possible differences in the arm-brain time between patients. In addition, the investigators will analyze the proportion of superior hypophyseal branches on the chiasm that luminesced from ICG.
Percentage of Patients with Post Operative Visual Acuity Impairment and Visual Field Defect
The investigators will evaluate the percentage of participants that present with decreased of visual acuity and any modality of visual field defect after the surgery. Postoperative visual acuity and visual field testing will be performed at 6 weeks postoperative follow up visit to evaluate chiasm function, including cranial nerve examination, bilateral number counting, letter reading, and number identification in 4 quadrants of peripheral vision. Visual evaluations will be performed by the ophthalmology service following our standard postoperative protocol.
Time frame: From the surgery to first post-operative follow up (6 weeks)
Plan to share: No
Start is estimated for Jul 2024; primary completion for Jul 2025, 12 months later.
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