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Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Primary Purpose

Peritoneal Metastases

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LUM Imaging System

About this trial

This is an interventional device feasibility trial for Peritoneal Metastases focused on measuring Gastrointestinal Cancer, Ovarian Cancer, Mesothelioma, Peritoneal surface malignancies

Eligibility Criteria

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

Inclusion Criteria:

Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
Subjects must be scheduled for surgical resection.
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 criteria listed below.
Subjects must have normal organ and marrow function as defined as:
- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- total bilirubin within normal institutional limits
- 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.
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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1st Tier Dose Level- LUM Imaging System

2nd Tier Dose Level- LUM Imaging System

3rd Tier Dose Level- LUM Imaging System

Optimal Dose Arm

Arm Description

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 on surgical tissue.

9 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 on surgical tissue.

6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.

12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data

Outcomes

Primary Outcome Measures

Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology

Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.

Secondary Outcome Measures

Number of patients with reported adverse events

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

Full Information

NCT ID

NCT03834272

First Posted

February 4, 2019

Last Updated

December 14, 2022

Sponsor

Lumicell, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03834272

Brief Title

Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Official Title

Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 18, 2019 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (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

Yes

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

The objective of this feasibility study is 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.

Detailed Description

Subjects will be recruited and screened at a single institution, Massachusetts General Hospital. All subjects will have an established diagnosis of metastases to the peritoneum from primary colonic, appendiceal, or ovarian cancer or mesothelioma and are scheduled for surgical debulking. This study consists of a dose escalation and timepoint evaluation phase and an evaluation and improvement phase following tumor detection algorithm development. 30 patients will be enrolled into this study. 18 into a dose escalation arm and 12 in the algorithm development phase.

6. Conditions and Keywords

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

Peritoneal Metastases

Keywords

Gastrointestinal Cancer, Ovarian Cancer, Mesothelioma, Peritoneal surface malignancies

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Dose Escalation

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1st Tier Dose Level- LUM Imaging System

Arm Type

Experimental

Arm Description

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 on surgical tissue.

Arm Title

2nd Tier Dose Level- LUM Imaging System

Arm Type

Experimental

Arm Description

9 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 on surgical tissue.

Arm Title

3rd Tier Dose Level- LUM Imaging System

Arm Type

Experimental

Arm Description

6 patients will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo on surgical tissue.

Arm Title

Optimal Dose Arm

Arm Type

Experimental

Arm Description

12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data

Intervention Type

Combination Product

Intervention Name(s)

LUM Imaging System

Intervention Description

Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.

Primary Outcome Measure Information:

Title

Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology

Description

Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

Number of patients with reported adverse events

Description

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

Time Frame

up to 5 weeks post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery. Subjects must be scheduled for surgical resection. 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 criteria listed below. Subjects must have normal organ and marrow function as defined as: Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL total bilirubin within normal institutional limits 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. 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

Jorge Ferrer, Ph.D.

Phone

617-4041040

jmferrer@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

James C Cusack, 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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James C Cusack, MD

12. IPD Sharing Statement

Plan to Share IPD

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Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

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