COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System

Quick Facts

Study Start:2021-09-30

Study Completion:2025-03-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04743310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

John Yu, MD

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: John Yu

John Yu, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-30

Study Completion Date2025-03-06

Study Record Updates