Using tozuleristide and Canvas imaging to detect brain tumors during surgery
A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged with the Canvas System
This study is testing if a new drug called tozuleristide, along with a special imaging system, can help surgeons find and remove brain tumors more accurately during surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04743310 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a single dose of tozuleristide combined with the Canvas imaging system during the surgical resection of primary central nervous system tumors. It aims to evaluate how well these tools can identify tumor tissue by measuring fluorescence in various types of CNS tumors, including high-grade and non-gadolinium enhancing tumors. The study will also assess the safety of the intervention and the accuracy of fluorescence in distinguishing tumor from non-tumoral tissue. Participants will undergo MRI to confirm the presence of a measurable tumor before enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults with measurable primary malignant central nervous system tumors or schwannomas requiring surgical resection.
Not a fit: Patients who are only undergoing diagnostic biopsies without intent to resect or those with serious ongoing medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of tumor removal during surgery, potentially leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using fluorescence-guided surgery for tumor detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: John Yu, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Navigator
- Email: cancer.trial.info@cshs.org
- Phone: 310-423-2133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.