Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Lumicell, Inc.
Study ID
NCT02584244
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LUM015 — DRUG
  • LUM 2.6 Imaging Device — DEVICE

Study Details

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.

Key Dates

Start date
Aug 4, 2016
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with colorectal cancer
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
  • Experimental: Patients with esophageal cancer
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
  • Experimental: Pancreatic cancer patients receiving neoadjuvant chemotherapy
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
  • Experimental: Pancreatic cancer patients not receiving neoadjuvant chemo
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
  • Experimental: Gastric cancer patients who have received neoadjuvant therapy
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
  • Experimental: Patients with early stage gastric cancer or precancerous lesions
    The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Primary Outcome Measure

Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Andrew Chan, MD, Ph.D

Find similar trials in Boston, MA

By condition
Colorectal cancerEsophageal cancerGastric cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Massachusetts General Hospital· Boston, MA

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