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Procedure

LUM Imaging System for Pancreatic Cancer

N/A

Waitlist Available

Led By Cristina Ferrone, MD

Research Sponsored by Lumicell, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with ECOG performance status of 0 or 1.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-14 days

Awards & highlights

Study Summary

This trial is testing a new imaging system to see if it can detect pancreatic cancer during surgery.

Who is the study for?

This trial is for adults over 18 with confirmed pancreatic cancer, planning to have surgery. They must be in good health apart from cancer, able to follow the study plan, and sign a consent form. Key health measures like white blood cell count and liver function need to be within certain limits.Check my eligibility

What is being tested?

The LUM Imaging System is being tested for its ability to detect primary pancreatic cancer and peritoneal invasion during surgery. This single-site study will develop a tumor detection algorithm specifically for this purpose.See study design

What are the potential side effects?

As this is an imaging system feasibility study, specific side effects are not detailed but may include typical risks associated with surgical procedures or contrast agents used in imaging such as allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My blood tests show normal organ function and healthy blood cell counts.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10-14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Correlate resected tissue with LUM Imaging System to identify imaging threshold

Side effects data

From 2020 Phase 2 trial • 234 Patients • NCT03321929

91%

Chromaturia

Seroma

Alanine aminotransferase increased

Contusion

Pruritus

Nausea

Haematoma

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

LUM Imaging System

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lum Imaging SystemExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUM Imaging System

2018

Completed Phase 2

~240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lumicell, Inc.Lead Sponsor

8 Previous Clinical Trials

939 Total Patients Enrolled

Cristina Ferrone, MDPrincipal InvestigatorMassachusetts General Hospital

2 Previous Clinical Trials

3,501 Total Patients Enrolled

Media Library

LUM Imaging System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04276909 — N/A

Pancreatic Cancer Clinical Trial 2023: LUM Imaging System Highlights & Side Effects. Trial Name: NCT04276909 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled in this clinical research endeavor?

"Contradicting information on clinicaltrials.gov displays that this trial is not currently actively enrolling patients; it was first listed in December 1st of 2023 and the latest update was February 7th 2022. However, there are 705 other studies looking for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Study of LUM Imaging System for Pancreatic Cancer

2026. "Feasibility Study of LUM Imaging System for Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04276909.