Colorectal CancerPhase 1/2NCT02584244
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
A Phase 1/2 study testing LUM015 and LUM 2.6 Imaging Device in people with Colorectal Cancer and Pancreatic Cancer, run by Lumicell, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer
- What is being tested?
- LUM015 and LUM 2.6 Imaging Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2016to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled.
- Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.
- Age of 18 years or older.
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects must have received and signed an informed consent form.
- Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
Show all 15Show fewer
- 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
- total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction)
- AST (SGOT)/ALT (SGPT) </= 2.5 X institutional upper limit of normal (</= 5 x ULN in cases of malignant biliary obstruction)
- Creatinine within normal institutional limits or creatinine clearance >/= 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Subjects with ECOG performance status of 0 or 1.
Who cannot join
- Subjects who have taken an investigational drug within 30 days of enrollment.
- Subjects with QTc interval > 480ms.
- Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG)
- History of allergic reaction to oral or intravenous contrast agents.
Show all 10Show fewer
- Pregnant women or lactating women
- Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
- HIV-positive individuals on combination antiretroviral therapy.
- Any subject for whom the investigator feels participation is not in the best interest of the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Andrew Chan, MD, Ph.D
About this study
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.
Read the detailed description
The overall goal of this feasibility study is to assess the initial safety and efficacy of a novel, intravenously administered cathepsin activatable imaging probe, LUM015, in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging Device.
All subjects will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and are scheduled for resection of their primary tumors.
Patients will be seen by their surgeon or endoscopist in an office visit and undergo routine preoperative testing within eight weeks of their planned procedure. During the pre-procedure visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed. These laboratory values and results of the history and physical will be used to confirm eligibility. For some patients, a pre-procedure visit is not required as part of standard treatment. Those patients may have a study-specific screening and pre-procedure laboratory tests at their local medical center. On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection. For colorectal and esophageal cases, LUM015 will be administered 2-6 hours prior to tumor resection. For pancreatic cases, given the variability in predicting the time to tumor resection relative to surgical start time, injection will occur 1 hour prior to planned surgical start time. Patients will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit.
All surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM Imaging Device and routine diagnostic assessment. Imaged areas showing high fluorescence will be marked to guide pathology evaluation and determine whether the area contains tumor. Samples of imaged areas showing low fluorescence signal will also be evaluated by pathology to determine whether the area only contains normal tissue. After imaging, part of this tissue will be fresh frozen for correlative studies.
The patients are expected to be admitted to the hospital for the surgical procedure and remain in the hospital post-surgery as indicated and required by the surgeon per standard of care treatment. While in the hospital, patients will be assessed for adverse events. Laboratory studies will also be performed during this time as a part of routine post-surgical care and to assess for any imaging agent related adverse events.
- Being tested
- LUM015, LUM 2.6 Imaging Device
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM015Drug
LUM 2.6 Imaging DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
| Patients with esophageal cancer | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
| Pancreatic cancer patients receiving neoadjuvant chemotherapy | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
| Pancreatic cancer patients not receiving neoadjuvant chemo | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
| Gastric cancer patients who have received neoadjuvant therapy | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
| Patients with early stage gastric cancer or precancerous lesions | Experimental | 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. Receives: Drug: LUM015; Device: LUM 2.6 Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results
Measured: 1 day
Secondary outcomes (1)
Number of safety events in humans with colorectal, pancreatic, and esophageal cancer.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start4 Aug 2016
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Six groups enrolling up to 11 patients each. Groups are patients with colorectal cancer, patients with esophageal cancer, patients with pancreatic cancer receiving neoadjuvant chemotherapy, patients with pancreatic cancer not receiving neoadjuvant chemotherapy, gastric cancer patients who have received neoadjuvant therapy, and patients with early stage gastric cancer or precancerous lesions
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew T Chan, M.D., Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584244
- Sponsor's protocol ID
- LUM-015/2.6-002
- Other IDs
- P50CA127003
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2015
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT02584244
- Acronym / sponsor ID
- LUM-015/2.6-002
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this feasibility study is to assess the initial safety and efficacy of a novel, intravenously administered cathepsin activatable imaging probe, LUM015, in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging Device.
All subjects will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and are scheduled for resection of their primary tumors.
Patients will be seen by their surgeon or endoscopist in an office visit and undergo routine preoperative testing within eight weeks of their planned procedure. During the pre-procedure visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed. These laboratory values and results of the history and physical will be used to confirm eligibility. For some patients, a pre-procedure visit is not required as part of standard treatment. Those patients may have a study-specific screening and pre-procedure laboratory tests at their local medical center. On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection. For colorectal and esophageal cases, LUM015 will be administered 2-6 hours prior to tumor resection. For pancreatic cases, given the variability in predicting the time to tumor resection relative to surgical start time, injection will occur 1 hour prior to planned surgical start time. Patients will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit.
All surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM Imaging Device and routine diagnostic assessment. Imaged areas showing high fluorescence will be marked to guide pathology evaluation and determine whether the area contains tumor. Samples of imaged areas showing low fluorescence signal will also be evaluated by pathology to determine whether the area only contains normal tissue. After imaging, part of this tissue will be fresh frozen for correlative studies.
The patients are expected to be admitted to the hospital for the surgical procedure and remain in the hospital post-surgery as indicated and required by the surgeon per standard of care treatment. While in the hospital, patients will be assessed for adverse events. Laboratory studies will also be performed during this time as a part of routine post-surgical care and to assess for any imaging agent related adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Six groups enrolling up to 11 patients each. Groups are patients with colorectal cancer, patients with esophageal cancer, patients with pancreatic cancer receiving neoadjuvant chemotherapy, patients with pancreatic cancer not receiving neoadjuvant chemotherapy, gastric cancer patients who have received neoadjuvant therapy, and patients with early stage gastric cancer or precancerous lesions
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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. |
| Patients with esophageal cancer | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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. |
| Pancreatic cancer patients receiving neoadjuvant chemotherapy | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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. |
| Pancreatic cancer patients not receiving neoadjuvant chemo | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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. |
| Gastric cancer patients who have received neoadjuvant therapy | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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. |
| Patients with early stage gastric cancer or precancerous lesions | Experimental | Drug: LUM015, Device: LUM 2.6 Imaging DeviceThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled.
- Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.
- Age of 18 years or older.
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects must have received and signed an informed consent form.
Key exclusion criteria (10 listed)
- Subjects who have taken an investigational drug within 30 days of enrollment.
- Subjects with QTc interval > 480ms.
- Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUM015 | Drug | Gastric cancer patients who have received neoadjuvant therapy, Pancreatic cancer patients not receiving neoadjuvant chemo, Pancreatic cancer patients receiving neoadjuvant chemotherapy, Patients with colorectal cancer, Patients with early stage gastric cancer or precancerous lesions, Patients with esophageal cancer |
| LUM 2.6 Imaging Device | Device | Gastric cancer patients who have received neoadjuvant therapy, Pancreatic cancer patients not receiving neoadjuvant chemo, Pancreatic cancer patients receiving neoadjuvant chemotherapy, Patients with colorectal cancer, Patients with early stage gastric cancer or precancerous lesions, Patients with esophageal cancer |
Primary outcome
Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results
Time frame: 1 day
1 secondary outcome
Number of safety events in humans with colorectal, pancreatic, and esophageal cancer.
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew T Chan, M.D., Ph.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LUM015 and LUM 2.6 Imaging Device in people with Colorectal Cancer and Pancreatic Cancer, run by Lumicell, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Ferrer, Ph.D (617-571-0592, jmferrr@lumicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.