Fluorescence Detection of Primary CNS Tumors

Condition: Primary central nervous system tumors

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • 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 (removal) is indicated

Key Exclusion Criteria:

  • Pregnant or breast-feeding or planning to conceive a child within 30 days
  • Individuals with ongoing serious medical conditions
  • Planned to undergo only a diagnostic biopsy procedure, without intent to remove tissue for therapeutic purposes

Study Name

IIT2020-09-Yu-BBIST001: A Phase II Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System (IRB no. 00001236)

Summary

This study focuses on individuals who have a primary central nervous system 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 central nervous system (CNS) tumors. Researchers aim to determine whether the use of tozuleristide and the Canvas imaging system may be useful to assist clinical decision-making during surgery.

Participants will receive one dose of tozuleristide before their planned surgery, during which the Canvas imaging system device will be used. This 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 it from nearby normal tissue such as brain and nerves.

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