Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumicell, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.
Age of 18 years or older.
Subjects must be able and willing to follow study procedures and instructions.
Disqualifiers
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects with QTc interval > 480ms.
Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
Trial design
Treatments tested in this trial
- LUM015
- LUM 2.6 Imaging Device
Treatment groups
66 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Lumicell, Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov