LUM Imaging for Peritoneal Tumors

Overseen By Kate Smith, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lumicell, Inc.

Must not be taking: Investigational drugs, Antiretrovirals

Disqualifiers: Pregnancy, Uncontrolled hypertension, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the LUM Imaging System for detecting cancer that has spread to the peritoneum from gastrointestinal cancer, ovarian cancer, or mesothelioma. The trial will explore different doses of the LUM015 drug, a new potential imaging agent, to determine the optimal dose for imaging during surgery. Individuals diagnosed with these types of cancer and scheduled for surgery might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking an investigational drug, you must stop at least 30 days before enrolling in the study.

What prior data suggests that the LUM Imaging System is safe for in vivo imaging of peritoneal tumors?

Research shows that the LUM Imaging System may help find tumors during surgery. In an earlier study, patients received LUM015, a special substance that makes cancer cells light up, making them easier to see and remove. The study found that most patients handled the treatment well, experiencing no serious side effects.

Safety remained a key focus, with regular checks to monitor any side effects. Researchers tested different doses to find the safest and most effective amount. This careful testing is common in early studies to ensure a treatment is safe before wider use.

Overall, while more research is needed, early results suggest that the LUM Imaging System is relatively safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LUM Imaging System because it offers a new way to detect peritoneal tumors during surgery. Unlike traditional methods, which often rely on visual inspection and palpation, the LUM Imaging System uses a special dye, LUM015, that makes cancerous tissues light up when viewed with the imaging device. This could potentially help surgeons identify and remove all cancerous tissues more accurately, reducing the chance of tumor remnants and improving patient outcomes. By precisely targeting tumors in real-time, this approach could lead to more effective surgeries and better recovery chances for patients.

What evidence suggests that the LUM Imaging System is effective for imaging peritoneal tumors?

Research shows that the LUM Imaging System, tested in this trial, could help surgeons see and remove cancer more effectively. Studies have demonstrated that this system can distinguish between cancer cells and healthy ones during surgery, reducing the chance of leaving cancer cells behind. In earlier research, surgeries using this system led to better outcomes by lowering the chances of cancer recurrence in mice. Surgeons found it useful for spotting leftover cancer cells during operations. Early results suggest it could be a helpful tool for treating tumors in the abdomen from gastrointestinal and ovarian cancers, as well as mesothelioma. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Greer, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with peritoneal metastases from gastrointestinal, ovarian, or mesothelioma cancers. They must be scheduled for surgery and have normal organ/marrow function. Excluded are those on recent investigational drugs, pregnant/nursing individuals, uncontrolled hypertension or illness, HIV-positive on antiretrovirals, allergy to contrast agents/PEG.

Inclusion Criteria

Subjects must be scheduled for surgical resection

Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery

Subjects must be able and willing to follow study procedures and instructions

Exclusion Criteria

You cannot have taken any experimental medications within the last month before joining the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dose Escalation

Participants receive a single dose of LUM015 at varying levels to determine the optimal dose

1 day

1 visit (in-person)

Algorithm Development

Participants receive the optimal dose of LUM015 and imaging is performed to develop the tumor detection algorithm

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LUM Imaging System

Trial Overview The LUM Imaging System is being tested for its ability to safely and effectively image cancer spread to the peritoneum in real-time during surgery. The study has two parts: a dose-finding phase followed by patient enrollment to refine the tumor detection algorithm.

How Is the Trial Designed?

Group I: 3rd Tier Dose Level- LUM Imaging System Experimental Treatment 1 Intervention

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. Some patients may be imaged with an additional imaging device.

Group II: 2nd Tier Dose Level- LUM Imaging System Experimental Treatment 1 Intervention

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. Some patients may be imaged with an additional imaging device.

Group III: 1st Tier Dose Level- LUM Imaging System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Lumicell, Inc.

Lead Sponsor

Trials

9

Recruited

910+

Citations

1. lumicell.com lumicell.com/feasibility-study-underway-to-assess-lumicell-technology-for-removing-ovarian-and-peritoneal-cancer-tumors-during-the-first-surgery/

Feasibility Study Underway to Assess ... The Lumicell System enables surgeons to visualize and distinguish cancer cells from healthy cells, so tumor cells aren't left behind during the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03834272

Feasibility of the LUM Imaging System for Peritoneal ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4794335/

A mouse-human phase 1 co-clinical trial of a protease ... Residual fluorescence in the tumor bed correlated with local recurrence, and image-guided surgery improved outcomes for mice. This intraoperative imaging system ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10788608/

Imaging Evaluation of Peritoneal Metastasis - PubMed Central This review summarizes the role and status of different imaging techniques, especially new imaging strategies such as spectral photon-counting CT, fibroblast ...

5. ovariancancernewstoday.com ovariancancernewstoday.com/2019/04/24/surgeons-test-lum-imaging-system-detect-cancer-cells/

Surgeons Will Test LUM Imaging System to Better Detect ... “Our study found that the Lumicell Imaging System was effective for real time identification of residual cancer intraoperatively. This is an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7210242/

Feasibility Study of a Novel Protease-Activated Fluorescent ... The LUM015 agent and LUM Imaging System allow rapid identification of residual tumor in the lumpectomy cavity of breast cancer patients and may reduce rates of ...

7. ctv.veeva.com ctv.veeva.com/study/feasibility-of-the-lum-imaging-system-for-peritoneal-surface-malignancies

Feasibility of the LUM Imaging System for Peritoneal Surface ... 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03834272?term=Lum&viewType=Table&rank=2

Feasibility of the LUM Imaging System for Peritoneal ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

9. lumicell.com lumicell.com/the-science-propelling-lumicell/

The Science Propelling Lumicell The Lumicell DVS aims to revolutionize the breast cancer resection process and find residual cancer that may otherwise be left behind.

10. link.springer.com link.springer.com/article/10.1007/s10549-021-06106-w

Performance of a novel protease-activated fluorescent ... The LUM Imaging System uses LUM015, a protease-activated fluorescent imaging agent that identifies residual tumor in the surgical cavity walls.