Prostate CancerPhase 1/2NCT03441464
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
A Phase 1/2 study testing LUM Imaging System in people with Prostate Cancer and Neoplasm, Residual, run by Lumicell, Inc. at 1 site in United States.
Trial summary
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Neoplasm, Residual
- 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
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 11 Feb 2021
- Phase
- Phase 1/2
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with clinically localized or locally advanced prostate cancer and scheduled for radical prostatectomy
- Age 40 years or older
- Able and willing to follow study procedures and instructions
- Received and signed informed consent form
- Otherwise healthy except for diagnosis of cancer
- Normal organ and marrow function as defined below:
Show all 13Show fewer
- Hemoglobin 13.9 - 16.3 g/dL
- Leukocytes 4500 - 11,000 uL
- Platelets 150,000 - 450,000 uL
- Total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) within normal institutional limits
- Creatinine within normal institutional limits or creatinine clearance within normal institutional limits
- ECOG performance status of 0 or 1
Who cannot join
- Known current substance addiction
- Have taken an investigational drug within 30 days of enrollment
- Received methylene blue prior to tissue excision
- QT Interval > 480ms
- Have not recovered from an adverse event due to pharmaceutical or diagnostic agent
- Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; subjects with known HTN should be under these values while under pharmaceutical therapy
Show all 13Show fewer
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
- 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
- Sexually active subjects unwilling/unable to use medically acceptable forms of contraception during study participation
- HIV-positive subjects on combination antiretroviral therapy
- Investigator feels subject's participation is not in the best interest of the subject
- Previously treated with local or systemic therapies to treat prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10044
About this study
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015).
Patients with an established diagnosis of prostate cancer and who are eligible for radical prostatectomy will be screened. Eligible patients will be enrolled and on the day of their planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients will be monitored for adverse events from time of injection through the first standard of care post-surgical follow-up visit.
Read the detailed description
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015).
Patients with an established diagnosis of adenocarcinoma of the prostate and who are eligible for radical prostatectomy will be screened. Patients will be seen by their surgeon in an office visit and undergo routine preoperative testing within 8 weeks of their planned procedure. After obtaining informed consent and confirming eligibility, patients will be enrolled and on the day of their planned surgery, LUM015 will be administered by bolus intravenous injection 2-6 hours prior to surgery. This injection is the only procedure that will be performed on patients outside of their routine care (standard of care).
LUM015 will be administered in a single dose between 0.5 -1.5 mg/kg in up to 9 patients. An additional 3 patients will not be injected with LUM015, but their specimens will undergo LUM imaging.
Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be sent to the pathology suite for imaging with the LUM imaging device and routine diagnostic assessment. Imaging will be performed on the resected specimens. Alternatively, specimens can also be imaged in the operating room. Imaged areas showing high fluorescence will be marked with ink 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. Additional resection will not be performed if a positive surgical margin is detected by imaging.
Patients are expected to be admitted to the hospital for the surgical procedure and will remain in the hospital post-surgery per standard of care treatment. Laboratory studies will be performed to assess for any imaging agent related adverse events prior to hospital discharge and at the standard of care post-surgical follow-up visit. Patients will be followed through their first standard of care post-surgical visit. Additionally, patients will be monitored for adverse events from time of injection through the first standard of care post-surgical visit. Patients with adverse events that are possibly related to LUM015 will be followed until resolution or stabilization of the adverse event.
- Conditions
- Prostate Cancer, Neoplasm, Residual
- Being tested
- LUM Imaging System
- Keywords
- Fluorescence, Prostate, Cancer detection
- Medical subject headings
- Prostatic Neoplasms, Neoplasm, Residual
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 resected tissue will be imaged ex vivo with the LUM imaging device.
| Study group | Role | What they receive |
|---|---|---|
| 1st Tier Dose Level | Experimental | 3 patients administered single dose of LUM015 at 0.5 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue. Receives: Combination Product: LUM Imaging System |
| 2nd Tier Dose Leel | Experimental | 3 patients administered single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue. Receives: Combination Product: LUM Imaging System |
| 3rd Tier Dose Level | Experimental | After evaluation of the fluorescence signal observed with the LUM imaging device in the three other cohorts,the subsequent 3 patients will receive a dose of 0.5-1.5 mg/kg. Receives: Combination Product: LUM Imaging System |
| Auto-fluorescence | No intervention | No LUM015 injection will be given to three (3) patients to measure baseline tissue fluorescence. The tissue will still be imaged ex-vivo using the LUM Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology
Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.
Measured: Day 1
Secondary outcomes (1)
Number of patients with reported adverse 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 posted22 Feb 2018
- Study start20 Mar 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Why it stopped: Interim analysis indicated a change in study design to collect in vivo data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashutosh Tewari, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441464
- Sponsor's protocol ID
- CL0005
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2018
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the LUM Imaging System for Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03441464
- Acronym / sponsor ID
- CL0005
- Conditions
- Prostate Cancer, Neoplasm, Residual
- Keywords
- Fluorescence, Prostate, Cancer detection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated a change in study design to collect in vivo data
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 22 Feb 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 primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015).
Patients with an established diagnosis of prostate cancer and who are eligible for radical prostatectomy will be screened. Eligible patients will be enrolled and on the day of their planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients will be monitored for adverse events from time of injection through the first standard of care post-surgical follow-up visit.
Detailed description
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015).
Patients with an established diagnosis of adenocarcinoma of the prostate and who are eligible for radical prostatectomy will be screened. Patients will be seen by their surgeon in an office visit and undergo routine preoperative testing within 8 weeks of their planned procedure. After obtaining informed consent and confirming eligibility, patients will be enrolled and on the day of their planned surgery, LUM015 will be administered by bolus intravenous injection 2-6 hours prior to surgery. This injection is the only procedure that will be performed on patients outside of their routine care (standard of care).
LUM015 will be administered in a single dose between 0.5 -1.5 mg/kg in up to 9 patients. An additional 3 patients will not be injected with LUM015, but their specimens will undergo LUM imaging.
Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be sent to the pathology suite for imaging with the LUM imaging device and routine diagnostic assessment. Imaging will be performed on the resected specimens. Alternatively, specimens can also be imaged in the operating room. Imaged areas showing high fluorescence will be marked with ink 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. Additional resection will not be performed if a positive surgical margin is detected by imaging.
Patients are expected to be admitted to the hospital for the surgical procedure and will remain in the hospital post-surgery per standard of care treatment. Laboratory studies will be performed to assess for any imaging agent related adverse events prior to hospital discharge and at the standard of care post-surgical follow-up visit. Patients will be followed through their first standard of care post-surgical visit. Additionally, patients will be monitored for adverse events from time of injection through the first standard of care post-surgical visit. Patients with adverse events that are possibly related to LUM015 will 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 |
|---|---|---|
| 1st Tier Dose Level | Experimental | Combination Product: LUM Imaging System3 patients administered single dose of LUM015 at 0.5 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue. |
| 2nd Tier Dose Leel | Experimental | Combination Product: LUM Imaging System3 patients administered single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue. |
| 3rd Tier Dose Level | Experimental | Combination Product: LUM Imaging SystemAfter evaluation of the fluorescence signal observed with the LUM imaging device in the three other cohorts,the subsequent 3 patients will receive a dose of 0.5-1.5 mg/kg. |
| Auto-fluorescence | No intervention | –No LUM015 injection will be given to three (3) patients to measure baseline tissue fluorescence. The tissue will still be imaged ex-vivo using the LUM Imaging Device |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosed with clinically localized or locally advanced prostate cancer and scheduled for radical prostatectomy
- Age 40 years or older
- Able and willing to follow study procedures and instructions
- Received and signed informed consent form
- Otherwise healthy except for diagnosis of cancer
Key exclusion criteria (13 listed)
- Known current substance addiction
- Have taken an investigational drug within 30 days of enrollment
- Received methylene blue prior to tissue excision
- QT Interval > 480ms
- Have not recovered from an adverse event due to pharmaceutical or diagnostic agent
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 resected tissue will be imaged ex vivo with the LUM imaging device. | Combination product | 1st Tier Dose Level, 2nd Tier Dose Leel, 3rd Tier Dose Level |
Primary outcome
Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology
Time frame: Day 1
Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.
1 secondary outcome
Number of patients with reported adverse events
Time frame: Up to 14 days post surgery
Results and safety
The study was stopped early (reason given: Interim analysis indicated a change in study design to collect in vivo data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Ashutosh Tewari, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 LUM Imaging System in people with Prostate Cancer and Neoplasm, Residual, 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 13 inclusion and 13 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 25 Feb 2022. 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?
The study was stopped early (reason given: Interim analysis indicated a change in study design to collect in vivo 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?
Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology (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 25 Feb 2022.