LUM Imaging System for Gastrointestinal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Lumicell, Inc.
Must not be taking: Investigational drugs, Antiretrovirals
Disqualifiers: Uncontrolled hypertension, Allergies to PEG, others
No Placebo Group
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.
12345Is 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.
56789How 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.
14101112Eligibility 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
+7 more
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
+7 more
Trial 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
Participant Groups
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.
6Treatment groups
Experimental Treatment
Group I: Patients with esophageal cancerExperimental Treatment2 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 lesionsExperimental Treatment2 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 cancerExperimental Treatment2 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 chemotherapyExperimental Treatment2 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 chemoExperimental Treatment2 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 therapyExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Lumicell, Inc.Lead Sponsor
National Cancer Institute (NCI)Collaborator
References
Opportunities in cancer imaging: a review of oesophageal, gastric and colorectal malignancies. [2021]The incidence of gastrointestinal (GI) malignancy is increasing worldwide. In particular, there is a concerning rise in incidence of GI cancer in younger adults. Direct endoscopic visualisation of luminal tumour sites requires invasive procedures, which are associated with certain risks, but remain necessary because of limitations in current imaging techniques and the continuing need to obtain tissue for diagnosis and genetic analysis; however, management of GI cancer is increasingly reliant on non-invasive, radiological imaging to diagnose, stage, and treat these malignancies. Oesophageal, gastric, and colorectal malignancies require specialist investigation and treatment due to the complex nature of the anatomy, biology, and subsequent treatment strategies. As cancer imaging techniques develop, many opportunities to improve tumour detection, diagnostic accuracy and treatment monitoring present themselves. This review article aims to report current imaging practice, advances in various radiological modalities in relation to GI luminal tumour sites and describes opportunities for GI radiologists to improve patient outcomes.
Assessment of Endoscopic Mucosal Healing of Ulcerative Colitis Using Linked Colour Imaging, a Novel Endoscopic Enhancement System. [2022]Mucosal healing and control of intestinal mucosal inflammation are important treatment goals for maintaining clinical remission in ulcerative colitis [UC] patients. Here, we investigated the efficacy of linked colour imaging [LCI], a novel endoscopic enhancement system, for diagnosing mucosal inflammation in UC patients.
Narrow-band imaging with magnifying endoscopy is accurate for detecting gastric intestinal metaplasia. [2021]To investigate the predictive value of narrow-band imaging with magnifying endoscopy (NBI-ME) for identifying gastric intestinal metaplasia (GIM) in unselected patients.
Advanced imaging and technology in gastrointestinal neoplasia: summary of the AGA-NCI Symposium October 4-5, 2004. [2021]Imaging and other advanced technologies for detection of gastrointestinal cancers are undergoing a major revolution on several fronts. This is facilitated by convergence of key technologies including advanced endoscopic-detection systems, more specific contrast agents, rapid and high-resolution cross-sectional imaging, and miniaturization of construction systems for making all imaging equipment smaller and less invasive. This convergence is occurring along traditional translational research pathways (clinical medicine-molecular biology) as well as nontraditional lines (clinical medicine-optical physics/engineering and molecular biology-optical physics/engineering). These new efforts are producing a wide array of technologies aimed at improving detection, classification, and monitoring of gastrointestinal neoplasia, especially for colorectal and esophageal cancer because of easier accessibility. A critical goal is to detect lesions at their premalignant stages, thereby permitting meaningful intervention. Inspired by these advances, the American Gastroenterological Association and the National Cancer Institute sponsored a symposium held in Bethesda, MD, from October 4-5, 2004, bringing together leading investigators with diverse backgrounds in imaging technology. The aims of this symposium were to summarize the state of the art and priorities for research in the coming decade in the field of imaging and advanced technology for gastrointestinal neoplasia. In this overview, we summarize the salient results of that symposium. The initial sections discuss the major technologies in each area of endoluminal imaging and molecular imaging followed by applications to specific diseases such as Barrett's esophagus and colon neoplasia. Each section focuses on the current state of the art then lists major priorities for research in the field.
Linked color imaging improves the endoscopic visibility of gastric mucosal cancers. [2020]Background and study aims  As a newly developed endoscopy technique, linked color imaging (LCI) provides very bright images with enhanced color tones. With the objective of improving the detection rate of gastric mucosal cancers, which are often difficult to detect, we examined the utility of LCI from the viewpoint of visibility. Patients and methods  The current study used 100 consecutive gastric mucosal cancers ≤ 20 mm in diameter. For each lesion, we selected one endoscopic image acquired by white-light imaging (WLI), blue-laser imaging (BLI) -bright, and LCI modes. Four endoscopists interpreted the images; using a previously reported scale, we scored the visibility level on a scale of 1 - 4. Results  The mean (± SD) visibility scores were 2.54 ± 1.10 for WLI, 3.02 ± 1.07 for BLI-bright, and 3.28 ± 0.97 for LCI. The score was significantly higher for BLI-bright compared with WLI ( P  < .001) and again higher for LCI compared with BLI-bright ( P  < .001). For the experts, the scores for BLI-bright and LCI were similar, but both were significantly higher than the score for WLI. For the trainees, there was no significant difference between the WLI and BLI-bright scores, but LCI score was significantly higher than those for WLI and BLI-bright scores. With regard to clinical characteristics, LCI particularly enhanced visibility of normochromic, flat and depressed lesions, which had the lowest visibility scores of all three modalities compared with those of the other lesions. Conclusion  LCI increased visibility and may contribute to early detection of gastric mucosal cancers.
A structured light laser probe for gastrointestinal polyp size measurement: a preliminary comparative study. [2022]Polyp size measurement is an important diagnostic step during gastrointestinal endoscopy, and is mainly performed by visual inspection. However, lack of depth perception and objective reference points are acknowledged factors contributing to measurement errors in polyp size. In this paper, we describe the proof-of-concept of a polyp measurement device based on structured light technology for future endoscopes.
Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging. [2021]Global anal cancer incidence is increasing. High resolution anoscopy (HRA) currently screens for anal cancer, although the definitive test remains unknown. To improve on intraluminal imaging of the anal canal, we conducted a first-in-human study to determine feasibility and safety of a high-resolution, wide field-of-view scanning endoscope. Fourteen patients, under an IRB-approved clinical study, underwent exam under anesthesia, HRA, and imaging with the experimental device. HRA findings were photographed using an in-line camera attached to the colposcope and compared with the scanning endoscope images. Patients were followed up within 2 weeks of the procedure. The imaging device is inserted into the anal canal and the intraluminal surface is digitally photographed in 10 s and uploaded to a computer monitor for review. Ten patients completed imaging with the device. Three patients were not imaged due to severe anal stenosis. One patient was not imaged due to technical device malfunction. The device images were compared to the HRA images. No adverse event attributable to the device was reported. The intraluminal scanning endoscope can be used for circumferential anal canal imaging and is safe for clinical use. Future clinical studies are needed to evaluate the performance of this device.
LED-based endoscopic light source for spectral imaging. [2021]Colorectal cancer is the United States 3rd leading cancer in death rates.1 The current screening for colorectal cancer is an endoscopic procedure using white light endoscopy (WLE). There are multiple new methods testing to replace WLE, for example narrow band imaging and autofluorescence imaging.2 However, these methods do not meet the need for a higher specificity or sensitivity. The goal for this project is to modify the presently used endoscope light source to house 16 narrow wavelength LEDs for spectral imaging in real time while increasing sensitivity and specificity. The process to do such was to take an Olympus CLK-4 light source, replace the light and electronics with 16 LEDs and new circuitry. This allows control of the power and intensity of the LEDs. This required a larger enclosure to house a bracket system for the solid light guide (lightpipe), three new circuit boards, a power source and National Instruments hardware/software for computer control. The results were a successfully designed retrofit with all the new features. The LED testing resulted in the ability to control each wavelength's intensity. The measured intensity over the voltage range will provide the information needed to couple the camera for imaging. Overall the project was successful; the modifications to the light source added the controllable LEDs. This brings the research one step closer to the main goal of spectral imaging for early detection of colorectal cancer. Future goals will be to connect the camera and test the imaging process.
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]An endoscope with a light-emitting diode (LED) light source which has a 2-mm close-distance observation function without magnification, has been marketed, enabling linked color imaging (LCI) and blue laser imaging (BLI) for tumor detection and characterization. We analyzed the efficacy of a LED endoscope compared to a LASER endoscope.
Imaging of gastrointestinal malignancies. [2019]Many advancements in the imaging of gastrointestinal malignancies have been seen in the past year. Endorectal ultrasound and magnetic resonance imaging with an endorectal surface coil allow for more accurate staging of the depth of bowel wall invasion by rectal carcinoma. Monoclonal antibody imaging may detect metastases not found by other modalities while computed tomography arterial portography and intraoperative ultrasound improve our ability to identify liver metastases. Endoscopic ultrasound is also useful in the preoperative assessment of esophageal cancer and pancreatic endocrine tumors.
Light-emitting diode-assisted narrow band imaging video endoscopy system in head and neck cancer. [2020]To validate the effectiveness of a newly developed light-emitting diode (LED)-narrow band imaging (NBI) system for detecting early malignant tumors in the oral cavity.
Correlation between narrow band imaging and nonneoplastic gastric pathology: a pilot feasibility trial. [2008]A novel narrow band imaging (NBI) system is able to visualize the mucosal and vascular network in the GI tract.