Feasibility Study Of LUM Imaging System For Pancreatic Cancer

Study Overview

Feasibility Study of LUM Imaging System for Pancreatic Cancer

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.

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.

Pancreatic Cancer

COMBINATION_PRODUCT: LUM Imaging System

CLP-00011

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-08-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-11
First Submitted that Met QC Criteria 2020-02-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-13
First Posted (ACTUAL) 2020-02-19	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Lum Imaging System Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device	COMBINATION_PRODUCT: LUM Imaging System LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Lum Imaging System

Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device

COMBINATION_PRODUCT: LUM Imaging System

LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.

Primary Outcome Measures	Measure Description	Time Frame
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	Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.	10-14 days

Secondary Outcome Measures	Measure Description	Time Frame
Correlate resected tissue with LUM Imaging System to identify imaging threshold	Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue.	10-14 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Cristina Ferrone, MD, Massachusetts General Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record