Pancreatic CancerNCT04276909
Feasibility Study of LUM Imaging System for Pancreatic Cancer
A study testing LUM Imaging System in people with Pancreatic Cancer, run by Lumicell, Inc. at 1 site in United States.
Trial summary
This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- LUM Imaging System
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 histological or cytological confirmation of pancreatic cancer on a biopsy prior to the operation with planned surgical resection. Subjects at any cancer stage will be enrolled.
- 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 otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below.
- Subjects must have normal organ and marrow function as defined below:
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- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
- Subjects with ECOG performance status of 0 or 1.
Who cannot join
- 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.
- Subjects who have taken an investigational drug within 30 days of enrollment.
- Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 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).
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- History of allergic reaction to any oral or intravenous contrast agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with QT interval > 470 ms.
- HIV-positive individuals on combination antiretroviral therapy are ineligible.
- 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.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery
This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.
Read the detailed description
This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged by the LUM imaging device.
Up to 30 subjects will be enrolled in this study. Subjects will be administered with LUM015 at a dose of 1.0 mg/kg. Due to the expected duration of these surgeries (up to 14 hours), all subjects will require LUM015 administration intraoperatively.
The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.
- Conditions
- Pancreatic Cancer
- Being tested
- LUM Imaging System
- Keywords
- Primary Pancreatic Cancer, Peritoneal Invasion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM Imaging SystemCombination product
LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.
| Study group | Role | What they receive |
|---|---|---|
| Lum Imaging System | Experimental | Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device Receives: Combination Product: LUM Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Measured: 10-14 days
Secondary outcomes (1)
Correlate resected tissue with LUM Imaging System to identify imaging threshold
Findings from imaging results with the LUM System will be correlated with pathology assessment of the resected tissue.
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study startJan 2026 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Study not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristina Ferrone, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276909
- Sponsor's protocol ID
- CLP-00011
- Status last verified
- Mar 2024
- First submitted
- 12 Aug 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery
- ClinicalTrials.gov ID
- NCT04276909
- Acronym / sponsor ID
- CLP-00011
- Conditions
- Pancreatic Cancer
- Keywords
- Primary Pancreatic Cancer, Peritoneal Invasion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Feb 2020 (actual)
- 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.
This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.
Detailed description
This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged by the LUM imaging device.
Up to 30 subjects will be enrolled in this study. Subjects will be administered with LUM015 at a dose of 1.0 mg/kg. Due to the expected duration of these surgeries (up to 14 hours), all subjects will require LUM015 administration intraoperatively.
The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lum Imaging System | Experimental | Combination Product: LUM Imaging SystemSingle dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection at the beginning of the surgery. All subjects will have intraoperative imaging using the LUM Imaging Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have histological or cytological confirmation of pancreatic cancer on a biopsy prior to the operation with planned surgical resection. Subjects at any cancer stage will be enrolled.
- 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 otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below.
Key exclusion criteria (11 listed)
- 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.
- Subjects who have taken an investigational drug within 30 days of enrollment.
- Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy.
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 |
|---|---|---|
| LUM Imaging SystemLUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device. | Combination product | Lum Imaging System |
Primary outcome
Assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery
Time frame: 10-14 days
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
1 secondary outcome
Correlate resected tissue with LUM Imaging System to identify imaging threshold
Time frame: 10-14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cristina Ferrone, MD 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 study testing LUM Imaging System in people with 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 12 inclusion and 11 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery (time frame: 10-14 days). 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 13 Mar 2024.