Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
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.
| Condition(s) | Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. Subjects must have received and signed an informed consent form. 6. Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure. 7. Subjects must have normal organ and marrow func |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Lumicell, Inc. |
| Locations | Boston, Massachusetts, United States |
| Start date | 2016-08-04 |
| NCT ID | NCT02584244 |
| Official listing | https://clinicaltrials.gov/study/NCT02584244 |