Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

This single-site, feasibility study 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.

Primary Outcome Measures

  • Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology [ Time Frame: 1 Day ]
    Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.

Secondary Outcome Measures

  • Number of patients with reported adverse events [ Time Frame: up to 5 weeks post surgery ]
    Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
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.

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: February 15th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.