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NCT02584244

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 32 days later.

See at-risk trials from Lumicell, Inc.

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Record History

All 15 versions: 15 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 2 words
    • Enrollment closed, study ongoing
    • Primary completion pushed from Dec 2026 to Feb 2027
    • Site details revised
  2. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Apr 2026 to Apr 2027
    v14
  3. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Apr 2025 to Apr 2026
    v13
  4. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Apr 2024 to Apr 2025
    v12
  5. Primary completion date: Mar 2023 to Dec 2023
    • Study completion date: Jun 2023 to Apr 2024
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: May 2022 to Mar 2023
    • Study completion date: Aug 2022 to Jun 2023
    v10
  2. Primary completion date: Nov 2021 to May 2022
    • Study completion date: Mar 2022 to Aug 2022
    v9
  3. Enrollment target: 44 to 66
    • Primary completion date: Dec 2020 to Nov 2021
    • Study completion date: Apr 2021 to Mar 2022
    • Study arms: 4 to 6
    v8
  4. Enrollment target: 21 to 44v7 Show 8 more changesShow less
    • Primary completion date: Nov 2018 to Dec 2020
    • Start date: May 2016 to Aug 4, 2016
    • Eligibility criteria expanded, about 6 words
    • Primary endpoint revised
    • Study completion date: Dec 2018 to Apr 2021
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 65 words
    • Study arms: 1 to 4
  5. Primary completion date: Feb 2018 to Nov 2018
    • Study completion date: Mar 2018 to Dec 2018
    v6
  6. Phase: Not applicable to Phase 1/2
    • Primary completion date: Dec 2017 to Feb 2018
    • Study completion date: Dec 2017 to Mar 2018
    v5
  7. Primary and study completion dates: Apr 2017 to Dec 2017v4
  8. Eligibility criteria shortened, about 45 words
    • Site details revised
    v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2015 to May 2016
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results
Timeframe: 1 day

Secondary (1)

Number of safety events in humans with colorectal, pancreatic, and esophageal cancer.

Arms and interventions

Patients with colorectal cancerExperimental

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.

Patients with esophageal cancerExperimental

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.

Pancreatic cancer patients receiving neoadjuvant chemotherapyExperimental

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.

Pancreatic cancer patients not receiving neoadjuvant chemoExperimental

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.

Gastric cancer patients who have received neoadjuvant therapyExperimental

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.

Patients with early stage gastric cancer or precancerous lesionsExperimental

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.

Drugs: LUM015

Devices: LUM 2.6 Imaging Device

Sites

1 site in 1 country

  • Massachusetts General HospitalBoston, Massachusetts, United States