Phase 2 N=336 Diagnostic

Indocyanine Green for Central Nervous System Tumors

Suspected Central Nervous System Tumors

Bottom Line

View on ClinicalTrials.gov: NCT02710240 ↗

Enrolled (actual)

336

Serious AEs

0.9%

Results posted

Oct 2021

Primary outcome: Primary: Sensitivity (SBR) — 5.49 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Indocyanine Green (ICG) (Drug); Intraoperative near-infrared (NIR) (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abramson Cancer Center at Penn Medicine
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity (SBR)	5.49	—

Summary

This study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. Subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. The primary goal is to observe what tissues fluoresce in the OR, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.

Eligibility Criteria

Inclusion Criteria

Adult patients 18 years of age and older Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria

Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process (children and neonates) Patients with non-MRI compatible implanted metallic foreign bodies Patients who due to severe claustrophobia cannot tolerate MRI scanning Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02710240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.