Clinical trial NCT03834272: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peritoneal Metastases
Keywords: Gastrointestinal Cancer
Ovarian Cancer
Mesothelioma
Peritoneal surface malignancies
Lead sponsor: Lumicell, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose Escalation
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
timeFrame: 1 Day
Secondary outcomes:
measure: Number of patients with reported adverse events
timeFrame: up to 5 weeks post surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan Greer, MD
role: PRINCIPAL_INVESTIGATOR
References: