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

Launched by JOHN YU · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help surgeons identify and remove brain tumors more effectively using a special dye called tozuleristide and an imaging system called Canvas. The goal is to see how well this combination can highlight tumors during surgery, making it easier for doctors to see cancerous tissue compared to healthy tissue. They will also look at how safe this method is and if the presence of glowing areas during surgery matches what doctors find on MRI scans afterward.

To participate in this trial, patients should have a specific type of brain tumor that can be measured on an MRI scan taken within the last 30 days. They also need to have normal kidney and liver function and should be well-recovered from any previous treatments. Throughout the trial, participants will receive a single dose of the dye before surgery, and they will be monitored for safety and how well the dye works during the procedure. It's important to note that the trial is open to adults of any gender, aged between 65 and 74, who meet these eligibility criteria.

Gender

ALL

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