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

• ClinicalTrials.gov Identifier: NCT04743310
• Recruitment Status: Recruiting
• First Posted: February 8, 2021
• Last Update Posted: November 30, 2021
• Sponsor: John Yu
• Collaborator: Blaze Bioscience Inc.
• Information provided by (Responsible Party): John Yu, Cedars-Sinai Medical Center

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Central Nervous System Tumor	Drug: tozuleristide; Device: Canvas imaging system; Procedure: Surgical resection of tumor	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tozuleristide with Canvas imaging system	Drug: tozuleristide; tozuleristide 24mg administered intravenously 1-24 hours prior to surgery; Device: Canvas imaging system; imaging device attached to surgical microscope; Procedure: Surgical resection of tumor; Standard of care surgical resection of tumor

Outcome Measures

Primary Outcome Measures :

1. Percentage of patients with fluorescence-positive primary tumor biopsy [ Time Frame: At the time of surgery ]
2. 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 ]
3. 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 Measures :

1. 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 ]
2. 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 ]
3. 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 Outcome Measures:

1. Incidence of adverse events [ 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 ]
   Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Kortnee Calkins; 310-285-7210; Kortnee.Calkins@cshs.org

Locations

United States, California

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Kortnee Calkins 310-285-7210 Kortnee.Calkins@cshs.org

Sub-Investigator: Ray Chu, MD

Sub-Investigator: Chirag Patil, MD

Sub-Investigator: Jeremy Rudnick, MD

Sub-Investigator: Jethro Hu, MD

Sub-Investigator: Serguei Bannykh, MD, PhD

Sub-Investigator: Ravi Prasad, MD

Sponsors and Collaborators

John Yu

Blaze Bioscience Inc.

Investigators

• Principal Investigator: John Yu, MD; Cedars-Sinai Medical Center

More Information

• Responsible Party: John Yu, Director, Surgical Neuro-Oncology, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT04743310
• Other Study ID Numbers: IIT2020-09-Yu-BBIST001
• First Posted: February 8, 2021
• Last Update Posted: November 30, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by John Yu, Cedars-Sinai Medical Center:

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

Additional relevant MeSH terms:

Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasms; Neoplasms by Site; Nervous System Diseases