This phase IV trial tests how well an imaging system (CONVIVO) works to discriminate normal tissue from abnormal tissue during brain tumor resection surgery for patients with intracranial tumors. For many types of brain tumors, complete removal of the tumor during surgery offers the greatest chance of the tumor not coming back or spreading. Even in cases where not all of the tumor can be removed, there is still a benefit to taking out as much of the tumor as possible. It is not always possible for the surgeon to tell what is normal tissue (brain) or abnormal tissue (tumor), particularly at the edges of the tumor. The CONVIVO system uses a type of imaging called confocal microscopy with an imaging agent called fluorescein sodium. Confocal microscopy is able to image the tissue at a cellular level in real-time. The CONVIVO system may help identify normal and abnormal tissue during surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT05139277.
Locations matching your search criteria
United States
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterStatus: Active
Contact: Linton T Evans
Phone: 603-650-5026
PRIMARY OBJECTIVE:
I. To evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery.
SECONDARY OBJECTIVES:
I. Determination of optimal time between fluorescein sodium (fluorescein) injection and tissue visualization or interrogation with the CONVIVO starting at 2-5 minutes after administration.
II. Optimal fluorescein dose for imaging.
III. Rate of uninterpretable or non-diagnostic images.
IV. Correlation between intraoperative confocal microscopy and coregistered magnetic resonance imaging (MRI) properties.
V. Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy.
VI. Correlation between in vivo confocal intraoperative microscopy and quantitative in vivo measurements of tissue fluorescein measurements.
VII. Correlation between visible blue-light fluorescence (400 nm filter) and quantitative fluorescence measurements of protoporphyrin IX (PPIX) and intraoperative confocal microscopy in patients receiving 5-aminolevulinic acid (5-ALA).
VIII. Extent of tumor resection.
IX. Adverse events.
X. Time to pathologic interpretation of intraoperative imaging compared to conventional interpretation of histology.
OUTLINE:
During standard of care resection surgery, patients receive fluorescein intravenously (IV). Patients then undergo intraoperative imaging with the CONVIVO system. Patients also undergo a biopsy during surgery.
After completion of surgery, patients are followed up between 2 days and 1 month.
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorLinton T Evans
