Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Lumicell, Inc.
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled. 2. Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy. 3. Age of 18 years or older. 4. Subjects must be able and willing to follow study procedures and instructions. 5. Su…
Interventions
- DrugLUM015
- DeviceLUM 2.6 Imaging Device
Location
- Massachusetts General HospitalBoston, Massachusetts