NCT02584244

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Lumicell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.

Detailed description

The overall goal of this feasibility study is to assess the initial safety and efficacy of a novel, intravenously administered cathepsin activatable imaging probe, LUM015, in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging Device. All subjects will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and are scheduled for resection of their primary tumors. Patients will be seen by their surgeon or endoscopist in an office visit and undergo routine preoperative testing within eight weeks of their planned procedure. During the pre-procedure visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed. These laboratory values and results of the history and physical will be used to confirm eligibility. For some patients, a pre-procedure visit is not required as part of standard treatment. Those patients may have a study-specific screening and pre-procedure laboratory tests at their local medical center. On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection. For colorectal and esophageal cases, LUM015 will be administered 2-6 hours prior to tumor resection. For pancreatic cases, given the variability in predicting the time to tumor resection relative to surgical start time, injection will occur 1 hour prior to planned surgical start time. Patients will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit. All surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM Imaging Device and routine diagnostic assessment. Imaged areas showing high fluorescence will be marked to guide pathology evaluation and determine whether the area contains tumor. Samples of imaged areas showing low fluorescence signal will also be evaluated by pathology to determine whether the area only contains normal tissue. After imaging, part of this tissue will be fresh frozen for correlative studies. The patients are expected to be admitted to the hospital for the surgical procedure and remain in the hospital post-surgery as indicated and required by the surgeon per standard of care treatment. While in the hospital, patients will be assessed for adverse events. Laboratory studies will also be performed during this time as a part of routine post-surgical care and to assess for any imaging agent related adverse events.

Conditions

• Colorectal Cancer
• Pancreatic Cancer
• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	LUM015
DEVICE	LUM 2.6 Imaging Device

Timeline

• Start date: 2016-08-04
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2015-10-22
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study