Health TrialsbyHealthPanel

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

ConditionsColorectal CancerPancreatic CancerEsophageal CancerGastric Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LUM015

    Drug

  • LUM 2.6 Imaging Device

    Device

Treatment groups

66 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Patients with colorectal cancerExperimental treatment 2 interventions
Group B: Patients with esophageal cancerExperimental treatment 2 interventions
Group C: Pancreatic cancer patients receiving neoadjuvant chemotherapyExperimental treatment 2 interventions
Group D: Pancreatic cancer patients not receiving neoadjuvant chemoExperimental treatment 2 interventions
Group E: Gastric cancer patients who have received neoadjuvant therapyExperimental treatment 2 interventions
Group F: Patients with early stage gastric cancer or precancerous lesionsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1 day

Secondary outcomes

1

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

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumicell, Inc.

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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