Pancreatic CancerPhase 1/2NCT04105062
LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
A Phase 1/2 study testing LS301 and Cancer Vision Goggles in people with Pancreatic Cancer and Liver Cancer, run by Washington University School of Medicine.
Trial summary
The preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the Cancer Vision Googles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Liver Cancer, Gastric Cancer
- What is being tested?
- LS301 and Cancer Vision Goggles
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with gastrointestinal cancers, including pancreas, liver, gastric cancer, gastrointestinal stromal tumors, and metastatic cancers undergoing surgical resection as standard of care treatment.
- At least 18 years of age.
- For the first cohort of patients enrolled, must have an ECG with no prolonged intervals.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. We do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counterions.
- Presence of underlying lung disease.
- Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
- Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.
About this study
Official title: Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
The preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the Cancer Vision Googles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 15% in pancreatic cancer, for example. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.
- Conditions
- Pancreatic Cancer, Liver Cancer, Gastric Cancer, Gastrointestinal Stromal Cancer, Metastatic Cancer
- Being tested
- LS301, Cancer Vision Goggles
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms, Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS301Drug
-LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine
Cancer Vision GogglesDevice
Also called CVG
-Non-significant risk device
| Study group | Role | What they receive |
|---|---|---|
| Phase I: LS301 Dose Level 1 (0.05 mg/kg) | Experimental | * The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.
* The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.
* The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. Receives: Drug: LS301; Device: Cancer Vision Goggles |
| Phase I: LS301 Dose Level 2 (0.075 mg/kg) | Experimental | * The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.
* The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.
* The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. Receives: Drug: LS301; Device: Cancer Vision Goggles |
| Phase I: LS301 Dose Level 3 (0.1 mg/kg) | Experimental | * The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.
* The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.
* The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. Receives: Drug: LS301; Device: Cancer Vision Goggles |
| Phase II: LS301 Dose determined in Phase I | Experimental | * The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery.
* The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed.
* The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. Receives: Drug: LS301; Device: Cancer Vision Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient
- Safety evaluation includes vital signs, clinical laboratory testing and ECG, measured pre- (within 10-15 minutes or 30 minutes of injection) and post-injection (within 30 minutes or/and at ~60 minutes).
- Adverse events will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From time of injection to 1 hour post-injection
Phase I only: Optimal imaging dose of LS301
- The optimal will be the dose at which fewer than 2 dose-limiting toxicities (DLTs) are observed and optimal image quality is observed. It need not be the maximum tolerated dose (MTD) if optimal image quality is observed at a lower dose than the MTD
- DLT is defined as any grade 2 or above toxicity that occurs during the hour after injection that is considered possibly, probably, or definitely related to LS301.
Measured: From time of injection to 1 hour post-injection
Phase II only: Ability of LS301 to predict presence of positive margins
- Margin status called by LS301 and CVG will be compared to the gold standard histopathological results
- The histopathological results of margin positivity has the following possible results: margin negative, margin positive at LS301 and CVG identified locations, margin positive at LS301 and CVG unidentified locations. Using LS301 and CVG, the exercised tissue will be considered to be margin positive and have ink marked at the identified locations if any positive margins are observed; otherwise, the margin is considered negative.
Measured: At the time of pathological analysis (within 2-3 days of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: One of the investigators is leaving the University.
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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- A rolling six design will be used to enroll patients in the phase 1 dose escalating portion of the study, during which LS301 will be administered intravenously at one of three doses. After the optimal dose has been determined, an additional 9 patients will be enrolled in the phase I expansion cohort to evaluate for safety. The optimal imaging dose of LS301 determined in phase I will be administered in 88 patients in the phase II portion of the study.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan C Fields, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105062
- Sponsor's protocol ID
- 201911165
- Status last verified
- Dec 2021
- First submitted
- 20 Sep 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
- ClinicalTrials.gov ID
- NCT04105062
- Acronym / sponsor ID
- 201911165
- Conditions
- Pancreatic Cancer, Liver Cancer, Gastric Cancer, Gastrointestinal Stromal Cancer, Metastatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the investigators is leaving the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2019 (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 preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by the Cancer Vision Googles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 15% in pancreatic cancer, for example. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- A rolling six design will be used to enroll patients in the phase 1 dose escalating portion of the study, during which LS301 will be administered intravenously at one of three doses. After the optimal dose has been determined, an additional 9 patients will be enrolled in the phase I expansion cohort to evaluate for safety. The optimal imaging dose of LS301 determined in phase I will be administered in 88 patients in the phase II portion of the study.
| Arm | Type | Receives |
|---|---|---|
| Phase I: LS301 Dose Level 1 (0.05 mg/kg) | Experimental | Drug: LS301, Device: Cancer Vision Goggles* The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery. * The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed. * The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. |
| Phase I: LS301 Dose Level 2 (0.075 mg/kg) | Experimental | Drug: LS301, Device: Cancer Vision Goggles* The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery. * The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed. * The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. |
| Phase I: LS301 Dose Level 3 (0.1 mg/kg) | Experimental | Drug: LS301, Device: Cancer Vision Goggles* The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery. * The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed. * The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. |
| Phase II: LS301 Dose determined in Phase I | Experimental | Drug: LS301, Device: Cancer Vision Goggles* The patient will undergo intravenous injection of LS301 4-24 hours prior to surgery. * The operating surgeon will conduct surgery as usual without using a device to visualize LS301 fluorescence. To prevent bias in data acquisition, a second surgeon will wear the CVG at the completion of the surgery to examine the excised tissue at the surgical margins and the surgical resection bed. * The operating surgeon will remain blinded to the fluorescence images throughout the operation. The examining surgeon will wear the CVG and image all six anatomical aspects (superior, inferior, anterior, posterior, medial and lateral) of the surgical specimen as well as the surgical cavity for LS301 fluorescence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed patients with gastrointestinal cancers, including pancreas, liver, gastric cancer, gastrointestinal stromal tumors, and metastatic cancers undergoing surgical resection as standard of care treatment.
- At least 18 years of age.
- For the first cohort of patients enrolled, must have an ECG with no prolonged intervals.
- Able to understand and willing to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. We do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counterions.
- Presence of underlying lung disease.
- Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
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 |
|---|---|---|
| LS301-LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine | Drug | Phase I: LS301 Dose Level 1 (0.05 mg/kg), Phase I: LS301 Dose Level 2 (0.075 mg/kg), Phase I: LS301 Dose Level 3 (0.1 mg/kg), Phase II: LS301 Dose determined in Phase I |
| Cancer Vision GogglesAlso: CVG-Non-significant risk device | Device | Phase I: LS301 Dose Level 1 (0.05 mg/kg), Phase I: LS301 Dose Level 2 (0.075 mg/kg), Phase I: LS301 Dose Level 3 (0.1 mg/kg), Phase II: LS301 Dose determined in Phase I |
Primary outcome
Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient
Time frame: From time of injection to 1 hour post-injection
* Safety evaluation includes vital signs, clinical laboratory testing and ECG, measured pre- (within 10-15 minutes or 30 minutes of injection) and post-injection (within 30 minutes or/and at ~60 minutes). * Adverse events will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Phase I only: Optimal imaging dose of LS301
Time frame: From time of injection to 1 hour post-injection
* The optimal will be the dose at which fewer than 2 dose-limiting toxicities (DLTs) are observed and optimal image quality is observed. It need not be the maximum tolerated dose (MTD) if optimal image quality is observed at a lower dose than the MTD * DLT is defined as any grade 2 or above toxicity that occurs during the hour after injection that is considered possibly, probably, or definitely related to LS301.
Phase II only: Ability of LS301 to predict presence of positive margins
Time frame: At the time of pathological analysis (within 2-3 days of surgery)
* Margin status called by LS301 and CVG will be compared to the gold standard histopathological results * The histopathological results of margin positivity has the following possible results: margin negative, margin positive at LS301 and CVG identified locations, margin positive at LS301 and CVG unidentified locations. Using LS301 and CVG, the exercised tissue will be considered to be margin positive and have ink marked at the identified locations if any positive margins are observed; otherwise, the margin is considered negative.
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 9 Dec 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Ryan C Fields, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LS301 and Cancer Vision Goggles in people with Pancreatic Cancer and Liver Cancer, run by Washington University School of Medicine.
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 4 inclusion and 6 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient (time frame: From time of injection to 1 hour post-injection). The study lists 3 primary outcomes in all. 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 9 Dec 2021.