Feasibility Study of LUM Imaging System for Pancreatic Cancer

NCT04276909 | Withdrawn FDA Device

• 1 other identifier: CLP-00011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Primary Pancreatic Cancer; Peritoneal Invasion

Outcome Measures

Primary Outcomes (1)

• 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.

  10-14 days

Secondary Outcomes (1)

• Correlate resected tissue with LUM Imaging System to identify imaging threshold

  10-14 days

Study Arms (1)

Lum Imaging System

EXPERIMENTAL

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

Combination Product: LUM Imaging System

Interventions

LUM Imaging System COMBINATION_PRODUCT

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

Lum Imaging System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lumicell, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Cristina Ferrone, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: February 19, 2020
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)