Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

Purpose

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.

Condition

  • Peritoneal Metastases

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose Escalation
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
1st Tier Dose Level- LUM Imaging System 		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.
  • Combination Product: LUM Imaging System
    Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.
Experimental
2nd Tier Dose Level- LUM Imaging System 		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.
  • Combination Product: LUM Imaging System
    Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.
Experimental
3rd Tier Dose Level- LUM Imaging System 		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.
  • Combination Product: LUM Imaging System
    Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.
Experimental
Optimal Dose Arm 		12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data
  • Combination Product: LUM Imaging System
    Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
James C Cusack, MD

More Details

Status
Recruiting
Sponsor
Lumicell, Inc.

Study Contact

Jorge Ferrer, Ph.D.
617-4041040
jmferrer@lumicell.com

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.