Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
The first 6 subjects will receive an intravenous injection of LUM015 intraoperatively with a dose of either 1.0 mg/kg or 1.5 mg/kg. The first three subjects will receive a dose of 1.0 mg/kg and if there are no adverse events the next three subject will receive the increased dose of 1.5 mg/kg. LUM015 will be given through a vein in the arm.
When the final dose of LUM015 has been determined, 12 additional subjects will be given that final dose.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1st Tier Dose Level- LUM Imaging System 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 and ex vivo on surgical tissue. |
Combination Product: LUM Imaging System
Patients will be injected with one of 2 study doses of LUM015 and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
|
| Experimental: 2nd Tier Dose Level- LUM Imaging System 3 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 and ex vivo on surgical tissue. |
Combination Product: LUM Imaging System
Patients will be injected with one of 2 study doses of LUM015 and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
|
| Experimental: 3rd Tier Dose Level- LUM Imaging System 12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data |
Combination Product: LUM Imaging System
Patients will be injected with one of 2 study doses of LUM015 and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
|
Outcome Measures
Primary Outcome Measures
- Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
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Subjects must be scheduled for surgical resection.
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Age of 18 years or older.
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Subjects must be able and willing to follow study procedures and instructions.
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Subjects must have received and signed an informed consent form.
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Subjects must be otherwise healthy except for the diagnosis of cancer, as per the criteria listed below.
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Subjects must have normal organ and marrow function as defined as:
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Leukocytes > 3,000/mcL
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Absolute neutrophil count > 1,500/mcL
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Platelets > 100,000/mcL
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total bilirubin within normal institutional limits
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AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
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Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
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Subjects with ECOG performance status of 0 or 1.
Exclusion Criteria:
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Subjects who are pregnant or nursing at the time of diagnosis.
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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.
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Subjects who have taken an investigational drug within 30 days of enrollment.
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Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
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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.
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History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
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History of allergic reaction to any oral or intravenous contrast agents.
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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.
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HIV-positive individuals on combination antiretroviral therapy are ineligible.
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Any subject for whom the investigator feels participation is not in the best interest of the subject.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Lumicell, Inc.
Investigators
- Principal Investigator: James C Cusack, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLP-00010