- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834272
Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies
Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Kate Smith, MPH, CCRP
- Phone Number: 7815918378 7815918378
- Email: kate@lumicell.com
Study Contact Backup
- Name: Jorge Ferrer, Ph.D.
- Phone Number: 617-4041040
- Email: jmferrer@lumicell.com
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- James C Cusack, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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
|
Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology
Time Frame: 1 Day
|
Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with reported adverse events
Time Frame: up to 5 weeks post surgery
|
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
|
up to 5 weeks post surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James C Cusack, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP-00010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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