Pancreatic Cancer
Conditions
Keywords
Primary Pancreatic Cancer, Peritoneal Invasion
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 pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.
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. 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.
Interventions
COMBINATION_PRODUCTLUM Imaging System
LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.
Sponsors
Lumicell, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 10-14 days | Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate resected tissue with LUM Imaging System to identify imaging threshold | 10-14 days | Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue. |
Countries
United States
Outcome results
None listed