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Feasibility Study of LUM Imaging System for Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LUM Imaging System

About this trial

This is an interventional other trial for Pancreatic Cancer focused on measuring Primary Pancreatic Cancer, Peritoneal Invasion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.
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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lum Imaging System

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04276909

First Posted

August 12, 2019

Last Updated

May 8, 2023

Sponsor

Lumicell, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04276909

Brief Title

Feasibility Study of LUM Imaging System for Pancreatic Cancer

Official Title

Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lumicell, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Primary Pancreatic Cancer, Peritoneal Invasion

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lum Imaging System

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

LUM Imaging System

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.

Time Frame

10-14 days

Secondary Outcome Measure Information:

Title

Correlate resected tissue with LUM Imaging System to identify imaging threshold

Description

Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue.

Time Frame

10-14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Felix Geissler, MD, PhD

Phone

7815918378

Ext

7815918378

felix@lumicell.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kate Smith, MPH, CCRP

Phone

7815918378

Ext

7815918378

kate@lumicell.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristina Ferrone, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Ferrone, MD

12. IPD Sharing Statement

Plan to Share IPD

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Feasibility Study of LUM Imaging System for Pancreatic Cancer

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