Status:
WITHDRAWN
Feasibility Study of LUM Imaging System for Pancreatic Cancer
Lead Sponsor:
Lumicell, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 p...
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 devic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04276909
Start Date
January 1 2026
End Date
January 1 2026
Last Update
March 13 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114