The overall objective of this study is to assess the safety and efficacy of the LUM
Imaging System in imaging primary and metastatic cancer in the brain. This includes
selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of
low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03717142.
The primary objective of this feasibility study is to identify an effective dose of
LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain.
The optimal dose will be used for future studies. Both normal brain tissue and tumor
tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System
is a combination product consisting of the LUM Imaging Device and the imaging agent
LUM015.
Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to
the brain, and scheduled for surgical resection, will be screened, recruited. On day of
scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to
using LUM Imaging System during surgery. LUM015 will be administered via peripheral
intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg.
Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of
distinct areas of grossly normal appearing brain tissue and, separately, images of
distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed
is scanned to record in vivo images. The resected tissue will also be imaged ex vivo.
All subjects will continue to be monitored until hospital discharge and followed through
their first standard of care post-surgical visit. Subjects with adverse events that are
determined to be possibly related to the investigational product will continue to be
followed until resolution or stabilization of the adverse event.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationLumicell, Inc.
