Low Grade Glioma of BrainNCT03717142
Feasibility of the LUM Imaging System for Detection of Cancer to the Brain
A study testing LUM Imaging System in people with Low Grade Glioma of Brain and Glioblastoma, run by Lumicell, Inc. at 1 site in United States.
Trial summary
The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma of Brain, Glioblastoma, Metastasis to Brain
- 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to 14 Jun 2024
- 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
- Has radiologic imaging with a presumed diagnosis of low grade gliomas, glioblastoma/ grade III glioma or cancer metastases to the brain and must be scheduled for surgical resection
- Male or female subjects 18 years of age or older
- Subjects must have normal liver, kidney, and bone marrow function as defined below:
- Leukocytes > 3,000/mcL
- Platelets > 100,000/mcL
- total bilirubin within normal institutional limits
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- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- Creatinine ≤ 1.5 mg/dL 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
- Subjects with ECOG performance status of 0 or 1
Who cannot join
- Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
- Subjects with a known current condition of substance addiction.
- Subjects who have taken an investigational drug within 30 days of enrollment or those who have not recovered from adverse events due to pharmaceutical or diagnostic agents.
- 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 stable within these ranges while under pharmaceutical therapy.
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
- History of allergic reaction to any oral or intravenous contrast agents.
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- 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 who are pregnant or nursing.
- 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 are ineligible because of the potential for pharmacokinetic interactions with LUM015.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Feasibility of the LUM Imaging System for in Vivo and Ex Vivo Detection of Cancer in Subjects with Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain
The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.
Read the detailed description
The primary objective of this feasibility study is to identify an effective dose of LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain. The optimal dose will be used for future studies. Both normal brain tissue and tumor tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System is a combination product consisting of the LUM Imaging Device and the imaging agent LUM015.
Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to the brain, and scheduled for surgical resection, will be screened, recruited. On day of scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to using LUM Imaging System during surgery. LUM015 will be administered via peripheral intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg.
Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of distinct areas of grossly normal appearing brain tissue and, separately, images of distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed is scanned to record in vivo images. The resected tissue will also be imaged ex vivo.
All subjects will continue to be monitored until hospital discharge and followed through their first standard of care post-surgical visit. Subjects with adverse events that are determined to be possibly related to the investigational product will continue to be followed until resolution or stabilization of the adverse event.
- Conditions
- Low Grade Glioma of Brain, Glioblastoma, Metastasis to Brain
- Being tested
- LUM Imaging System
- Keywords
- Fluorescence, Brain, Cancer detection
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM Imaging SystemCombination product
Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
| Study group | Role | What they receive |
|---|---|---|
| Auto-fluorescence | No intervention | No LUM015 injection will be given to three (3) patients, in each indication, to measure baseline tissue fluorescence. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. |
| 1st Tier Dose Level | Experimental | 3 patients, in each indication, will be administered a single dose of LUM015 at 1.0 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. Receives: Combination Product: LUM Imaging System |
| 2nd Tier Dose Level | Experimental | 3 patients, in each indication, will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. Receives: Combination Product: LUM Imaging System |
| 3rd Tier Dose Level | Experimental | After an interim analysis, the dosing for the 3 patients, in each indication, will be administered a single dose of LUM015 of no greater than 3.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. Receives: Combination Product: LUM Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015
Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.
Measured: Day 1
Secondary outcomes (1)
Number of reported safety events
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity
Measured: up to 14 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start3 May 2019
- Primary completion13 Sep 2023
- Study completion14 Jun 2024
Why it stopped: Initial data indicated a change in study design required prior to collecting additional data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Glioma of BrainStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Antonio Chiocca, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717142
- Sponsor's protocol ID
- CL0004
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2018
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the LUM Imaging System for in Vivo and Ex Vivo Detection of Cancer in Subjects with Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain
- ClinicalTrials.gov ID
- NCT03717142
- Acronym / sponsor ID
- CL0004
- Conditions
- Low Grade Glioma of Brain, Glioblastoma, Metastasis to Brain
- Keywords
- Fluorescence, Brain, Cancer detection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial data indicated a change in study design required prior to collecting additional data.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 24 Oct 2018 (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.
The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.
Detailed description
The primary objective of this feasibility study is to identify an effective dose of LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain. The optimal dose will be used for future studies. Both normal brain tissue and tumor tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System is a combination product consisting of the LUM Imaging Device and the imaging agent LUM015.
Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to the brain, and scheduled for surgical resection, will be screened, recruited. On day of scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to using LUM Imaging System during surgery. LUM015 will be administered via peripheral intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg.
Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of distinct areas of grossly normal appearing brain tissue and, separately, images of distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed is scanned to record in vivo images. The resected tissue will also be imaged ex vivo.
All subjects will continue to be monitored until hospital discharge and followed through their first standard of care post-surgical visit. Subjects with adverse events that are determined to be possibly related to the investigational product will continue to be followed until resolution or stabilization of the adverse event.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Auto-fluorescence | No intervention | –No LUM015 injection will be given to three (3) patients, in each indication, to measure baseline tissue fluorescence. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. |
| 1st Tier Dose Level | Experimental | Combination Product: LUM Imaging System3 patients, in each indication, will be administered a single dose of LUM015 at 1.0 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. |
| 2nd Tier Dose Level | Experimental | Combination Product: LUM Imaging System3 patients, in each indication, will be administered a single dose of LUM015 at 2.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. |
| 3rd Tier Dose Level | Experimental | Combination Product: LUM Imaging SystemAfter an interim analysis, the dosing for the 3 patients, in each indication, will be administered a single dose of LUM015 of no greater than 3.0 mg/kg. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has radiologic imaging with a presumed diagnosis of low grade gliomas, glioblastoma/ grade III glioma or cancer metastases to the brain and must be scheduled for surgical resection
- Male or female subjects 18 years of age or older
- Subjects must have normal liver, kidney, and bone marrow function as defined below:
- 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
- Subjects with ECOG performance status of 0 or 1
Key exclusion criteria (10 listed)
- Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
- Subjects with a known current condition of substance addiction.
- Subjects who have taken an investigational drug within 30 days of enrollment or those who have not recovered from adverse events due to pharmaceutical or diagnostic agents.
- 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 stable within these ranges 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 |
|---|---|---|
| LUM Imaging SystemPatients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device. | Combination product | 1st Tier Dose Level, 2nd Tier Dose Level, 3rd Tier Dose Level |
Primary outcome
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015
Time frame: Day 1
Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.
1 secondary outcome
Number of reported safety events
Time frame: up to 14 days post surgery
Results and safety
The study was stopped early (reason given: Initial data indicated a change in study design required prior to collecting additional data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
E. Antonio Chiocca, MD, PhD principal investigator
Brigham and Women's 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 Low Grade Glioma of Brain and Glioblastoma, 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 10 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: stopped early, as of the sponsor's last update on 15 Jan 2025. 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 stopped early (reason given: Initial data indicated a change in study design required prior to collecting additional data.). Results are not available in the source record.
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?
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015 (time frame: Day 1). 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 15 Jan 2025.