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

Primary Purpose

Central Nervous System Tumor

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

tozuleristide

Canvas imaging system

Surgical resection of tumor

About this trial

This is an interventional treatment trial for Central Nervous System Tumor focused on measuring neurosurgery, brain tumor, spinal cord tumor, surgical resection, glioma, astrocytoma, glioblastoma, ependymoma, medulloblastoma, pineocytoma, meningioma, germ cell tumor, craniopharyngioma, oligoastrocytoma, pineoblastoma, extent of resection, maximal safe resection, neuropathology, vestibular schwannomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tozuleristide with Canvas imaging system

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with fluorescence-positive primary tumor biopsy

True positive rate of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all tumor-positive tissue biopsies

True negative rate of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all tumor-negative tissue biopsies

Secondary Outcome Measures

Positive predictive value of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all fluorescence-positive tissue biopsies

Negative predictive value of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all fluorescence-negative tissue biopsies

Extent of residual tumor measured on post-operative magnetic resonance imaging scans among all patients with evidence of residual fluorescence at the time of surgery

Full Information

NCT ID

NCT04743310

First Posted

February 4, 2021

Last Updated

August 29, 2023

Sponsor

John Yu

Collaborators

Blaze Bioscience Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04743310

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2021 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

John Yu

Collaborators

Blaze Bioscience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Tumor

Keywords

neurosurgery, brain tumor, spinal cord tumor, surgical resection, glioma, astrocytoma, glioblastoma, ependymoma, medulloblastoma, pineocytoma, meningioma, germ cell tumor, craniopharyngioma, oligoastrocytoma, pineoblastoma, extent of resection, maximal safe resection, neuropathology, vestibular schwannomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tozuleristide with Canvas imaging system

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

tozuleristide

Intervention Description

tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery

Intervention Type

Device

Intervention Name(s)

Canvas imaging system

Intervention Description

imaging device attached to surgical microscope

Intervention Type

Procedure

Intervention Name(s)

Surgical resection of tumor

Intervention Description

Standard of care surgical resection of tumor

Primary Outcome Measure Information:

Title

Percentage of patients with fluorescence-positive primary tumor biopsy

Time Frame

At the time of surgery

Title

True positive rate of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all tumor-positive tissue biopsies

Time Frame

At the time of surgery

Title

True negative rate of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all tumor-negative tissue biopsies

Time Frame

At the time of surgery

Secondary Outcome Measure Information:

Title

Positive predictive value of fluorescence, defined as the percentage of tumor-positive and fluorescence-positive tissue biopsies among all fluorescence-positive tissue biopsies

Time Frame

At the time of surgery

Title

Negative predictive value of fluorescence, defined as the percentage of tumor-negative and fluorescence-negative tissue biopsies among all fluorescence-negative tissue biopsies

Time Frame

At the time of surgery

Title

Extent of residual tumor measured on post-operative magnetic resonance imaging scans among all patients with evidence of residual fluorescence at the time of surgery

Time Frame

At the time of surgery

Other Pre-specified Outcome Measures:

Title

Incidence of adverse events

Description

Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Time Frame

From the time of study drug administration 1-24 hours prior to surgery, until 30 days after surgery or until receiving additional therapy for the central nervous system tumor, whichever comes first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trial Navigator

Phone

310-423-2133

cancer.trial.info@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Yu, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Navigator

Phone

310-423-2133

cancer.trial.info@cshs.org

First Name & Middle Initial & Last Name & Degree

Ray Chu, MD

First Name & Middle Initial & Last Name & Degree

Chirag Patil, MD

First Name & Middle Initial & Last Name & Degree

Jeremy Rudnick, MD

First Name & Middle Initial & Last Name & Degree

Jethro Hu, MD

First Name & Middle Initial & Last Name & Degree

Serguei Bannykh, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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