Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03579602 |
Recruitment Status :
Recruiting
First Posted : July 6, 2018
Last Update Posted : December 20, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatric Central Nervous System Tumor | Drug: tozuleristide Device: Canvas System | Phase 2 Phase 3 |
Subjects who provide voluntary written informed consent, or have it provided by their legally acceptable representative, will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.
Surgical excision will occur at least 1 hour and no more than 36 hours after tozuleristide administration. Surgery will be performed by a neurosurgeon and the Canvas will be operated by a designated Imaging Operator. Fluorescence of tumor and ambiguous tissue during surgery will be assessed and scored. Biopsy samples of these tumor and ambiguous tissues will be collected for pathology analysis.
All subjects will be monitored for safety during their participation in the study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Subjects will be randomized 1:10 to 1 of 2 study arms. Subjects in arm 1 (~9% of subjects) will not receive tozuleristide but will undergo neurosurgery and imaging will be performed with the Canvas. Subjects in arm 2 (~91% of subjects) will receive tozuleristide and will undergo neurosurgery and imaging will be performed with the Canvas. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Pathology assessment and post-operative MRI assessment will be blinded to fluorescence data. |
Primary Purpose: | Other |
Official Title: | A Randomized, Blinded Study of Fluorescence Detection of Pediatric Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System |
Actual Study Start Date : | November 26, 2018 |
Estimated Primary Completion Date : | April 2020 |
Estimated Study Completion Date : | July 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1 (no tozuleristide)
Subjects randomized to Arm 1 (~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System.
|
Device: Canvas System
All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Other Name: mSIRIS |
Experimental: Arm 2 (tozuleristide treated)
Subjects randomized to Arm 2 (~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System.
|
Drug: tozuleristide
Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor.
Other Names:
Device: Canvas System All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Other Name: mSIRIS |
- Sensitivity and specificity of tozuleristide fluorescence to detect tumor in equivocal (ambiguous) tissue during surgery when imaged with the Canvas system [ Time Frame: During surgery (which occurs at least 1 hour post tozuleristide administration) ]Sensitivity and specificity of tozuleristide imaged with the Canvas system to fluorescently identify tumor in equivocal tissue will be evaluated based on assessments made by the surgeon and imaging operator. These measures will be compared to the sensitivity and specificity of surgical designation of equivocal tissue without fluorescence.
- Safety - number of patients with adverse events [ Time Frame: AEs will be collected from day of randomization until Day 8. Subjects will be contacted monthly for up to 3 months post-surgery for safety assessments. ]Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
- Extent of resection [ Time Frame: At completion of surgery and up to 72 hours post-surgery for MRI assessment. If additional MRIs are obtained within 3 months post-surgery, they will be submitted for central MRI review. ]Extent of resection will be evaluated by the surgeon and by central review of post-operative magnetic resonance images (MRI). Extent of resection will be designated in the following categories: gross total resection (GTR; all tumor removed), near total resection (NTR; bulk of tumor removed), sub-total resection (STR; residual tumor present).
- Concentration of tozuleristide in the blood (pharmacokinetics) [ Time Frame: Subjects in Arm 2 only will have blood samples collected at 2 time points: One, within 30 minutes after tozuleristide administration and one between 30 minutes and 180 minutes after tozuleristide administration. ]Tozuleristide concentration in the blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
- Performance of the Canvas system [ Time Frame: After completion of surgery ]The surgeon and imaging operator will complete a survey to evaluate the usability of the Canvas during surgery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Month to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must be >1 month and ≤30 years of age at the time of study enrollment
- Subjects must have MRI obtained within 30 days of study enrollment documenting a measurable lesion consistent with a pediatric primary CNS tumor for which maximal safe resection is indicated
- Adequate renal function
- Adequate liver function
-
Prior therapy: 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:
- Radiation therapy: subjects may not have had radiation therapy to the area of tumor planned to be resected within 28 days of study enrollment
- Chemotherapy: at least 14 days from any myelosuppressive chemotherapy (28 days if prior nitrosourea) and if prior chemotherapy, must have an absolute neutrophil count recovery of ≥ 1000/mm3 following count nadir
- Biologic: at least 7 days from any anti-neoplastic biologic agent (at least 3 half-lives since last administration of monoclonal antibodies)
- Immunotherapy: at least 42 days after completion of any cellular immunotherapy, such as CAR-T cell therapy
- Prior surgery for CNS tumors is allowed
- Written informed consent must be obtained from the subject or parent or legal guardian prior to the conduct of study activities. Routine clinical tests, e.g., MRI, clinical laboratory studies, may be used for screening requirements. Assent, when appropriate, will be obtained according to institutional guidelines.
- The risks of treatment with tozuleristide during pregnancy have not been evaluated. Female subjects of child-bearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization and, if participating in sexual activity that could lead to pregnancy, must use 2 reliable methods of contraception simultaneously for 30 days after surgery. Male subjects must agree not to attempt to father a child and, if participating in sexual activity that could lead to pregnancy, must use 2 reliable methods of contraception simultaneously for 30 days after surgery if their partner is of child-bearing potential.
Exclusion Criteria:
- Pregnancy and contraception: Subjects who are pregnant or breast-feeding or planning to conceive a child within 30 days are not eligible. Males and females of childbearing potential must agree to use 2 effective forms of contraception from the time of enrollment until 30 days post-surgery
- Subjects with on-going serious medical conditions (poorly controlled asthma, diabetes, heart disease) 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 (e.g., stereotactic pontine biopsy)
- Subjects who in the opinion of the investigator are not willing or able to comply with randomization procedures or other study-required study procedures and observations. Subjects previously enrolled and randomized to Arm 1 (control) are not eligible for re-enrollment unless a second surgery is required by standard of care.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579602
Contact: PNOC Regulatory | (415) 502-1600 | PNOC_Regulatory@ucsf.edu |
United States, Washington | |
Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: CBDC Intake CBDCintake@seattlechildrens.org | |
Principal Investigator: Sarah Leary, MD |
Principal Investigator: | Sarah Leary, MD | Seattle Children's Hospital |
Responsible Party: | Blaze Bioscience Inc. |
ClinicalTrials.gov Identifier: | NCT03579602 History of Changes |
Other Study ID Numbers: |
BB-006 PNOC012 ( Other Identifier: Pacific Pediatric Neuro-Oncology Consortium ) |
First Posted: | July 6, 2018 Key Record Dates |
Last Update Posted: | December 20, 2018 |
Last Verified: | December 2018 |
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 | |
Pediatric Postmarket Surveillance of a Device Product: | No |
Keywords provided by Blaze Bioscience Inc.:
Tumor Paint tozuleristide Canvas imaging system BLZ-100 |
CNS tumor brain cancer pediatrics fluorescence guided surgery |
Additional relevant MeSH terms:
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |