NCT03717142

Feasibility of the LUM Imaging System for Detection of Cancer to the Brain

Feasibility of the LUM Imaging System for in Vivo and Ex Vivo Detection of Cancer in Subjects with Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Lumicell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Grade Glioma of Brain
• Glioblastoma
• Metastasis to Brain

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LUM Imaging System	Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.

Timeline

• Start date: 2019-05-03
• Primary completion: 2023-09-13
• Completion: 2024-06-14
• First posted: 2018-10-24
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study