LUM Imaging System for Gastrointestinal Cancer

Overseen By Kate Smith, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lumicell, Inc.

Must not be taking: Investigational drugs, Antiretrovirals

Disqualifiers: Uncontrolled hypertension, Allergies to PEG, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.

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.

What data supports the effectiveness of the LUM Imaging System treatment for gastrointestinal cancer?

The research highlights advancements in imaging technologies for gastrointestinal cancers, which aim to improve detection and monitoring. Although not specific to the LUM Imaging System, these advancements suggest potential benefits in using advanced imaging systems for better cancer detection and treatment outcomes. ^{1 2 3 4 5}

Is the LUM Imaging System safe for use in humans?

The LUM Imaging System, evaluated under different names, has been studied for safety in humans. In a study involving a high-resolution scanning endoscope, no adverse events were reported, indicating it is safe for clinical use. ^{5 6 7 8 9}

How does the LUM Imaging System treatment for gastrointestinal cancer differ from other treatments?

The LUM Imaging System is unique because it uses advanced imaging technology to detect gastrointestinal cancers at an early stage, potentially before they become malignant. This system focuses on improving detection and monitoring through non-invasive imaging, unlike traditional methods that often require invasive procedures. ^{1 4 10 11 12}

Research Team

Andrew Chan, MD, Ph.D

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with confirmed gastrointestinal cancers (esophageal, colorectal, or pancreatic) who are scheduled for surgery. They must have normal organ function and blood counts, be able to follow study procedures, and not be pregnant. Participants should use contraception during the study.

Inclusion Criteria

I am willing and able to follow the study's procedures and instructions.

My cancer is at any stage.

Subjects must have received and signed an informed consent form

Exclusion Criteria

I have recovered from side effects of treatments or tests received over 4 weeks ago.

I am HIV-positive and on combination antiretroviral therapy.

Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-8 weeks

1 visit (in-person)

Pre-procedure

Routine preoperative testing and study-specific screening, including history, physical examination, and laboratory studies

1 day

1 visit (in-person)

Treatment

Administration of LUM015 by intravenous injection prior to tumor resection and imaging of surgical specimens

1 day

1 visit (in-person)

Hospitalization

Patients remain in the hospital post-surgery for monitoring of adverse events and routine post-surgical care

Varies based on standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment until their first post-operative visit

Until first post-operative visit

Treatment Details

Interventions

• LUM015
• LUM 2.6 Imaging Device

Trial Overview The LUM Imaging System's safety and effectiveness in identifying cancerous tissue during surgery is being tested. It involves a drug called LUM015 used with an imaging device to highlight tumors in the digestive tract.

Participant Groups

Group I: Patients with esophageal cancer Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Group II: Patients with early stage gastric cancer or precancerous lesions Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Group III: Patients with colorectal cancer Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Group IV: Pancreatic cancer patients receiving neoadjuvant chemotherapy Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Group V: Pancreatic cancer patients not receiving neoadjuvant chemo Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Group VI: Gastric cancer patients who have received neoadjuvant therapy Experimental Treatment 2 Interventions

The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.

Who Is Running the Clinical Trial?

Lumicell, Inc.

Lead Sponsor

Trials

9

Recruited

910+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The incidence of gastrointestinal (GI) cancers is rising, particularly among younger adults, highlighting the need for effective diagnostic and treatment strategies.

Current advancements in non-invasive radiological imaging techniques are crucial for improving the detection, diagnosis, and monitoring of GI malignancies, potentially enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities in cancer imaging: a review of oesophageal, gastric and colorectal malignancies. Foley, KG., Pearson, B., Riddell, Z., et al.[2021]

Linked colour imaging (LCI) is an effective endoscopic enhancement system for diagnosing mucosal inflammation in ulcerative colitis (UC) patients, showing strong correlation with histopathological grading.

LCI classification can provide more detailed insights into mucosal inflammation than traditional Mayo endoscopic scores, potentially aiding in predicting patient outcomes and non-relapse rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Endoscopic Mucosal Healing of Ulcerative Colitis Using Linked Colour Imaging, a Novel Endoscopic Enhancement System. Uchiyama, K., Takagi, T., Kashiwagi, S., et al.[2022]

Narrow-band imaging with magnifying endoscopy (NBI-ME) demonstrated high sensitivity (80%) and specificity (96%) for identifying gastric intestinal metaplasia (GIM) in a study of 100 patients undergoing upper endoscopy for various gastrointestinal issues.

The technique effectively correlates the appearance of light blue crests (LBC) with histological findings of GIM, allowing for targeted biopsies and improving diagnostic accuracy in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrow-band imaging with magnifying endoscopy is accurate for detecting gastric intestinal metaplasia. Savarino, E., Corbo, M., Dulbecco, P., et al.[2021]

Recent advancements in imaging technologies for gastrointestinal cancers, such as enhanced endoscopic systems and specific contrast agents, are significantly improving the detection and monitoring of cancers like colorectal and esophageal cancer.

The primary goal of these innovations is to identify premalignant lesions early, allowing for timely interventions that could prevent the progression to cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced imaging and technology in gastrointestinal neoplasia: summary of the AGA-NCI Symposium October 4-5, 2004. Wallace, MB., Sullivan, D., Rustgi, AK.[2021]

Linked color imaging (LCI) significantly improved the visibility of gastric mucosal cancers compared to traditional white-light imaging (WLI) and blue-laser imaging (BLI), with mean visibility scores of 3.28 for LCI versus 2.54 for WLI and 3.02 for BLI.

LCI was particularly effective in enhancing the visibility of difficult-to-detect lesions, such as normochromic, flat, and depressed lesions, suggesting it may aid in the early detection of gastric mucosal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linked color imaging improves the endoscopic visibility of gastric mucosal cancers. Kitagawa, Y., Suzuki, T., Hara, T., et al.[2020]

A new polyp measurement device using structured light technology significantly improves accuracy in measuring polyp size compared to traditional visual assessment, reducing the median estimation error from 2.2 mm to 1.5 mm.

User satisfaction was highest for the structured light probe (7.92 out of 10), indicating that while it takes longer to use (54.75 seconds per polyp), it is preferred over visual assessment and other tools, and it does not obstruct the endoscope's tool channel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured light laser probe for gastrointestinal polyp size measurement: a preliminary comparative study. Visentini-Scarzanella, M., Kawasaki, H., Furukawa, R., et al.[2022]

A first-in-human study involving 14 patients demonstrated that a high-resolution, wide field-of-view scanning endoscope is safe for imaging the anal canal, with no adverse events reported during the procedure.

The device successfully captured circumferential images of the anal canal in 10 patients, suggesting its feasibility for improving anal cancer screening, although further studies are needed to assess its diagnostic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging. Lai, LL., Invernizzi, M., White, M., et al.[2021]

A new endoscopic light source was successfully developed by retrofitting an existing Olympus CLK-4 system with 16 narrow wavelength LEDs, enhancing the potential for real-time spectral imaging in colorectal cancer detection.

This modification aims to improve the sensitivity and specificity of colorectal cancer screening compared to traditional white light endoscopy, moving closer to the goal of early detection through advanced imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LED-based endoscopic light source for spectral imaging. Browning, CM., Mayes, S., Favreau, P., et al.[2021]

The LED endoscope demonstrated a diagnostic accuracy of 77.0% for tumor detection, which is slightly higher than the 65.6% accuracy of the LASER endoscope without magnification, indicating its effectiveness in identifying tumors.

The LED endoscope provided significantly higher brightness values compared to the LASER endoscope, which likely contributed to improved tumor detection and characterization, especially for smaller lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of tumor characterization and tumor detectability of linked color imaging and blue laser imaging with an LED endoscope compared to a LASER endoscope. Yoshida, N., Dohi, O., Inoue, K., et al.[2021]

Recent advancements in imaging techniques, such as endorectal ultrasound and MRI with an endorectal coil, have improved the accuracy of staging rectal cancer by better assessing how deeply the cancer has invaded the bowel wall.

New imaging methods, including monoclonal antibody imaging and computed tomography arterial portography, enhance the detection of metastases, particularly in the liver, which is crucial for effective treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of gastrointestinal malignancies. Trenkner, SW., Thompson, WM.[2019]

The newly developed LED-narrow band imaging (NBI) system effectively detected early malignant tumors in the oral cavity, revealing typical brown spots associated with squamous cell carcinoma in all six patients studied.

This pilot study suggests that the LED-NBI system could serve as a valuable adjunctive tool for early oral cancer detection, with advantages such as lower power consumption and higher luminous efficiency, although further large-scale studies are needed to confirm its accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light-emitting diode-assisted narrow band imaging video endoscopy system in head and neck cancer. Chang, HJ., Wang, WH., Chang, YL., et al.[2020]

The novel narrow band imaging (NBI) system demonstrated high sensitivity (89%) and specificity (78%) for diagnosing normal mucosa or mild gastritis in a pilot study of 47 patients undergoing upper endoscopy.

NBI also showed promising results for identifying specific gastric conditions, with 75% sensitivity and 88% specificity for H. pylori gastritis, and 80% sensitivity and 100% specificity for intestinal metaplasia, indicating its potential as a reliable diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between narrow band imaging and nonneoplastic gastric pathology: a pilot feasibility trial. Bansal, A., Ulusarac, O., Mathur, S., et al.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Opportunities in cancer imaging: a review of oesophageal, gastric and colorectal malignancies. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of Endoscopic Mucosal Healing of Ulcerative Colitis Using Linked Colour Imaging, a Novel Endoscopic Enhancement System. [2022]

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

Narrow-band imaging with magnifying endoscopy is accurate for detecting gastric intestinal metaplasia. [2021]

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

Advanced imaging and technology in gastrointestinal neoplasia: summary of the AGA-NCI Symposium October 4-5, 2004. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Linked color imaging improves the endoscopic visibility of gastric mucosal cancers. [2020]

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

A structured light laser probe for gastrointestinal polyp size measurement: a preliminary comparative study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging. [2021]

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

LED-based endoscopic light source for spectral imaging. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

The efficacy of tumor characterization and tumor detectability of linked color imaging and blue laser imaging with an LED endoscope compared to a LASER endoscope. [2021]

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

Imaging of gastrointestinal malignancies. [2019]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Light-emitting diode-assisted narrow band imaging video endoscopy system in head and neck cancer. [2020]

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

Correlation between narrow band imaging and nonneoplastic gastric pathology: a pilot feasibility trial. [2008]