Phase 1, 2 Trials to Assess Imaging System for Gastrointestinal Cancer Detection
Researchers are seeking to assess the initial safety and efficacy of LUM015 imaging of colorectal, pancreatic, and esophageal cancers using the LUM 2.6 imaging device.
Title: Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers (ClinicalTrials.gov Identifier: NCT02584244)
Description: An interventional clinical trial is being conducted to assess the initial safety and efficacy of LUM015 imaging of colorectal, pancreatic, and esophageal cancers using the LUM 2.6 imaging device, which is a novel, intravenously administered cathepsin-activated imaging probe.
All enrolled patients will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and a scheduled resection of their primary tumors.
Enrolled patients will receive a bolus intravenous injection of LUM015 2 hours to 6 hours before their surgery. All patients will be monitored for adverse events throughout their hospital stay, with follow-up continuing until their first postoperative visit. All specimens collected during surgery will be sent for imaging using the LUM 2.6 imaging device and routine diagnostic assessment.
The primary outcome of the research is to determine the optimal dose of LUM015 to be used according to tissue type based on optimal LUM015 activity in normal versus tumor tissue. Secondary outcomes include assessing toxicity in patients with gastrointestinal cancers by monitoring adverse events and determining initial efficacy of LUM015 in labeling gastrointestinal cancers for molecular imaging.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02584244.
Status: The trial is open and recruiting patients as of May 2016. The estimated enrollment for the trial is 21 patients.
- Clinicaltrials.gov. Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers. NCT02584244. https://clinicaltrials.gov/ct2/show/NCT02584244. Accessed December 17, 2018.