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

John Yu

Status and phase

Completed

Phase 2

Conditions

Central Nervous System Tumor

Treatments

Drug: tozuleristide

Procedure: Surgical resection of tumor

Device: Canvas imaging system

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04743310

IIT2020-09-Yu-BBIST001

Details and patient eligibility

About

The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.

The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide 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 remaining fluorescence at the time of surgery corresponds to remaining 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).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.

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