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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the LUM Imaging System treatment for peritoneal tumors?

The research highlights the challenges in detecting peritoneal tumors with current imaging technologies, suggesting that new imaging systems like LUM could potentially improve detection. While not directly about LUM, advancements in imaging are crucial for better treatment outcomes in peritoneal tumors. ^{1 2 3 4 5}

Is LUM Imaging for peritoneal tumors safe for humans?

The polarization-enhanced laparoscopy (PEL) prototype, which is similar to LUM Imaging, was tested in humans and found to be safe, although there were some technical limitations like reduced illumination. ^{6 7 8 9 10}

How does LUM Imaging for peritoneal tumors differ from other treatments?

LUM Imaging for peritoneal tumors is unique because it focuses on using imaging technology to better visualize and assess the extent of peritoneal tumors, which can help in planning surgical procedures and treatment strategies. This approach is different from traditional treatments that primarily rely on surgery and chemotherapy, as it aims to improve the accuracy of tumor detection and evaluation. ^{2 3 5 7 11}

Research Team

Jonathan Greer, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

Age of 18 years or older

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

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

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)

Treatment Details

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.

Participant Groups

Group I: Optimal Dose Arm Experimental Treatment 1 Intervention

12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data

Group II: 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.

Group III: 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.

Group IV: 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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[State-of-the-art imaging of peritoneal carcinomatosis]. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Imaging of peritoneal carcinomatosis. [2016]

3. China pubmed.ncbi.nlm.nih.gov

Analysis and external validation of a nomogram to predict peritoneal dissemination in gastric cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Follow-up of ovarian and primary peritoneal carcinoma: the value of physical examination in patients with pretreatment elevated CA125 levels. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

The maximum standardized uptake value and extent of peritoneal involvement may predict the prognosis of patients with recurrent ovarian cancer after primary treatment: A retrospective clinical study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Non-invasive imaging of implanted peritoneal carcinomatosis in mice using PET and bioluminescence imaging. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Invasive Imaging and Scoring of Peritoneal Metastases in Small Preclinical Animal Models Using Ultrasound: A Preliminary Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

"PAUSE": a method for communicating radiological extent of peritoneal malignancy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Radiation-absorbed dose estimates to normal organs following intraperitoneal 186Re-labeled monoclonal antibody: methods and results. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of a polarization-enhanced laparoscopy prototype for improved intra-operative visualization of peritoneal metastases. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Multidetector CT of peritoneal carcinomatosis from ovarian cancer. [2016]