Fluorescence Detection of Adult Primary Central Nervous System Tumors

What is the Purpose of this Study?

This study focuses on individuals who have a primary central nervous system (CNS) tumor and are planning to undergo surgery to remove the tumor. The purpose of the study is to examine the investigational use of a drug called tozuleristide and the Canvas imaging system device during surgical resection (removal) of primary CNS tumors. Researchers aim to determine whether the use of tozuleristide and the Canvas imaging system may be useful in assisting clinical decision-making during surgery. Participants will receive 1 dose of tozuleristide before their planned surgery, during which the Canvas imaging system device will be used. The device attaches to a surgical microscope and is used to detect fluorescence (shining) of the study drug (tozuleristide), which helps identify CNS tumors and distinguish them from nearby normal tissue such as brain and nerves.


Eligibility

  • * MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary malignant central nervous system tumor for which maximal safe resection is indicated OR MRI obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary schwannoma enhancing tumor in the cerebellopontine angle for which maximal safe resection is indicated.
  • * Adequate renal and liver function
  • * Subjects with prior therapy are eligible provided they have recovered from any acute toxic effects of prior therapy and have sufficient time interval prior to enrollment.
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2020-09-Yu-BBIST001: A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged with the Canvas System

Study Details
Disease Type/Condition

Brain Tumors

Principal Investigator

Yu, John

Co-Investigators

Chirag Patil, Jeremy Rudnick, Jethro Hu, Ray Chu, Xuemo Fan

Age Group

Adult

Phase

II

IRB Number

STUDY00001236

ClinicalTrials.gov ID

NCT04743310

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Brain Tumors

Principal Investigator

Yu, John

Age Group

Adult

Phase

II

IRB Number

IIT2020-09-YU-BBIST001

ClinicalTrials.gov ID

NCT04743310

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org