Feasibility Study of LUM Imaging System for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged by the LUM imaging device. Up to 30 subjects will be enrolled in this study. Subjects will be administered with LUM015 at a dose of 1.0 mg/kg. Due to the expected duration of these surgeries (up to 14 hours), all subjects will require LUM015 administration intraoperatively. The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Official Title
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Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Combination Product: LUM Imaging System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have histological or cytological confirmation of pancreatic cancer on a biopsy prior to the operation with planned surgical resection. Subjects at any cancer stage will be enrolled. Age of 18 years or older. Subjects must be able and willing to follow study procedures and instructions. Subjects must have received and signed an informed consent form. Subjects must be otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below. Subjects must have normal organ and marrow function as defined below: Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. Subjects with ECOG performance status of 0 or 1. Exclusion Criteria: Subjects who are pregnant or nursing at the time of diagnosis Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. Subjects who have taken an investigational drug within 30 days of enrollment. Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents. Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy. History of allergic reaction attributed to drugs containing polyethylene glycol (PEG). History of allergic reaction to any oral or intravenous contrast agents. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects with QT interval > 470 ms. HIV-positive individuals on combination antiretroviral therapy are ineligible. Any subject for whom the investigator feels participation is not in the best interest of the subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lum Imaging System<br>Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device | Combination Product: LUM Imaging System<br>* LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity. | 10-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate resected tissue with LUM Imaging System to identify imaging threshold | Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue. | 10-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Pancreatic Cancer, Peritoneal Invasion