Feasibility Study of LUM Imaging System for Pancreatic Cancer
NCT04276909 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-03-13
Summary
This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.
Conditions
Interventions
- COMBINATION_PRODUCT
-
LUM Imaging System
LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.
Sponsors & Collaborators
-
Lumicell, Inc.
lead INDUSTRY
Principal Investigators
-
Cristina Ferrone, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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