Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Study Overview
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Brief Summary
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The objective of this feasibility study is to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment of additional patients to develop the tumor detection algorithm.

Detailed Description
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Subjects will be recruited and screened at a single institution, Massachusetts General Hospital. All subjects will have an established diagnosis of metastases to the peritoneum from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for surgical debulking. This study consists of a dose escalation and timepoint evaluation phase and an evaluation and improvement phase following tumor detection algorithm development. 30 patients will be enrolled into this study. 18 into a dose escalation arm and 12 in the algorithm development phase.

Official Title
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Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies

Conditions
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Peritoneal Metastases

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 histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery. Subjects must be scheduled for surgical resection. 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 criteria listed below. Subjects must have normal organ and marrow function as defined as: Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL total bilirubin within normal institutional limits 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. 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: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose Escalation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st Tier Dose Level- LUM Imaging System<br>3 patients will be administered a single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue. | Combination Product: LUM Imaging System<br>* Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.<br>|
| Experimental: 2nd Tier Dose Level- LUM Imaging System<br>9 patients will be administered a single dose of LUM015 at 1.5 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue. | Combination Product: LUM Imaging System<br>* Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.<br>|
| Experimental: 3rd Tier Dose Level- LUM Imaging System<br>6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue. | Combination Product: LUM Imaging System<br>* Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.<br>|
| Experimental: Optimal Dose Arm<br>12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data | Combination Product: LUM Imaging System<br>* Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology | Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with reported adverse events | Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity. | up to 5 weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Cancer, Ovarian Cancer, Mesothelioma, Peritoneal surface malignancies