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ICG Group for Indocyanine Green

N/A
Waitlist Available
Led By Ezequiel Goldschmidt, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the surgery to first post-operative follow up (6 weeks)
Awards & highlights

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.

Eligible Conditions
  • Indocyanine Green
  • Skull Base Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the surgery to first post-operative follow up (6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the surgery to first post-operative follow up (6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Patients with Post Operative Visual Acuity Impairment and Visual Field Defect

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICG GroupExperimental Treatment1 Intervention
Eligible participants are those diagnosed with suprasellar lesions undergoing ICG angiography during endoscopic endonasal resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine Green
2008
Completed Phase 2
~1050

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,846 Total Patients Enrolled
Ezequiel Goldschmidt, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
20 Total Patients Enrolled
~27 spots leftby Jul 2025