Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the use of tozuleristide and the Canvas imaging system during surgical resection of primary central nervous system tumors, to identify which tumor types demonstrate detectable fluorescence following administration of 24 mg tozuleristide and imaged with the Canvas imaging system during surgical resection, and, among tumors that demonstrate fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue. The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of residual fluorescence at the time of surgery corresponds to residual tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Yu
• Collaborator: Blaze Bioscience Inc.

Criteria

Inclusion Criteria:

• 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

• 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.

Exclusion Criteria:

• Pregnant, breast-feeding, or planning to conceive a child within 30 days

• Ongoing serious medical conditions such that participation in the study could put the subject at increased risk of worsening their condition

• Subjects planned to undergo only a diagnostic biopsy procedure, without intent to resect tissue for therapeutic purposes

• Subjects for whom radiographic evidence suggests a non-intra-axial primary brain tumor