ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery

NCT06501716 | Not Yet Recruiting

• 1 other identifier: 24-41191
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indocyanine Green; Skull Base Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  From the surgery to first post-operative follow up (6 weeks)

Study Arms (1)

ICG Group

Eligible participants are those diagnosed with suprasellar lesions undergoing ICG angiography during endoscopic endonasal resection.

Procedure: Indocyanine Green

Interventions

Indocyanine Green PROCEDURE

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.

ICG Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.

You may not qualify if:

• Underage patients (younger than 18 y.o).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (4)

• Osorio RC, Aabedi AA, El-Sayed IH, Gurrola J 2nd, Goldschmidt E. Superior Hypophyseal Artery Intraoperative Indocyanine Green Angiogram as a Predictor of Postoperative Visual Function After Endoscopic Endonasal Surgery. Oper Neurosurg. 2023 Oct 1;25(4):379-385. doi: 10.1227/ons.0000000000000809. Epub 2023 Jun 27.

  PMID: 37366631 BACKGROUND

• Shahein M, Prevedello DM, Beaumont TL, Ismail K, Nouby R, Palettas M, Prevedello LM, Otto BA, Carrau RL. The role of indocyanine green fluorescence in endoscopic endonasal skull base surgery and its imaging correlations. J Neurosurg. 2020 Nov 13;135(3):923-933. doi: 10.3171/2020.6.JNS192775. Print 2021 Sep 1.

  PMID: 33186906 BACKGROUND

• Ramesh R, Gurrola JG 2nd, Goldschmidt E. Use of Real-Time Superior Hypophyseal Artery Indocyanine Green Angiogram During Endoscopic Resection of a Third Ventricular Craniopharyngioma: 2-Dimensional Operative Video. Oper Neurosurg. 2025 Jan 1;28(1):123-124. doi: 10.1227/ons.0000000000001225. Epub 2024 Jun 7. No abstract available.

  PMID: 38847508 BACKGROUND

• Lee MH, Lee TK. Application of fusion-fluorescence imaging using indocyanine green in endoscopic endonasal surgery. J Clin Neurosci. 2022 Apr;98:45-52. doi: 10.1016/j.jocn.2022.01.023. Epub 2022 Feb 4.

  PMID: 35131724 BACKGROUND

MeSH Terms

Conditions

Skull Base Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ezequiel Goldschmidt, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezequiel Goldschmidt, MD, PhD

CONTACT

415.514.6482; eze.goldschmidt@ucsf.edu

Daniel Quintana, BA

CONTACT

9094418999; Daniel.Quintana@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 15, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)