[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06501716":3,"trial-entities:NCT06501716":86,"trial-summary:NCT06501716":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":40,"std_ages":46,"locations":49,"central_contacts":58,"overall_officials":68,"references":71,"see_also_links":85},"NCT06501716","24-41191","ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery","I See G: Superior Hypophyseal Artery Intraoperative Indocyanine Green Angiogram as a Predictor of Postoperative Visual Function After Endoscopic Endonasal Surgery","UNKNOWN","2025-12","2024-07","2024-07-22","University of California, San Francisco","OTHER",false,"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.",null,[18,19],"Indocyanine Green","Skull Base Neoplasms",[],"OBSERVATIONAL",[],{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":18,"description":29,"armGroupLabels":30},"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.",[31],"ICG Group",[33],{"measure":34,"description":35,"timeFrame":36},"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)",[],"ALL","18 Years",{"inclusion":41,"exclusion":43,"raw_text":45},[42],"The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.",[44],"Underage patients (younger than 18 y.o).","Inclusion Criteria:\n\n* The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.\n\nExclusion Criteria:\n\n* Underage patients (younger than 18 y.o).",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":12,"city":51,"state":52,"zip":53,"country":54,"geoPoint":55},"San Francisco","California","94143","United States",{"lat":56,"lon":57},37.77493,-122.41942,[59,64],{"name":60,"role":61,"phone":62,"email":63},"Ezequiel Goldschmidt, MD, PhD","CONTACT","415.514.6482","eze.goldschmidt@ucsf.edu",{"name":65,"role":61,"phone":66,"email":67},"Daniel Quintana, BA","9094418999","Daniel.Quintana@ucsf.edu",[69],{"name":60,"affiliation":12,"role":70},"PRINCIPAL_INVESTIGATOR",[72,76,79,82],{"pmid":73,"type":74,"citation":75},"37366631","BACKGROUND","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\u002Fons.0000000000000809. Epub 2023 Jun 27.",{"pmid":77,"type":74,"citation":78},"33186906","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\u002F2020.6.JNS192775. Print 2021 Sep 1.",{"pmid":80,"type":74,"citation":81},"38847508","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\u002Fons.0000000000001225. Epub 2024 Jun 7. No abstract available.",{"pmid":83,"type":74,"citation":84},"35131724","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\u002Fj.jocn.2022.01.023. Epub 2022 Feb 4.",[],{"nct_id":4,"conditions":87,"biomarkers":92},[88,89,90,91],"Craniopharyngioma","Meningioma","Pituitary Neuroendocrine Tumor","Skull Base Neoplasm",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study involving 40 participants. It is not specified if it is randomized or blinded.","completed","ICG Angiogram for Visual Function After Brain Tumor Surgery","This study is looking at how a special dye called Indocyanine Green (ICG) can help doctors predict your vision after surgery for certain brain tumors. These tumors, like meningiomas, craniopharyngiomas, and pituitary adenomas, are located near your optic nerves (the nerves that help you see). During surgery, ICG is injected to help doctors see the blood flow around these nerves. The goal is to see if using ICG during surgery can help predict any vision problems you might have up to 6 weeks after the operation. You may be able to join if you are an adult (18 or older) having endonasal endoscopic surgery for one of these tumors.","Your vision will be followed up to 6 weeks after surgery.",109,"You will undergo tumor resection surgery, during which Indocyanine Green (ICG) will be administered. Your vision will be assessed from surgery until your first post-operative follow-up at 6 weeks.","Not stated in the trial record.",[18],"v2"]