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One of the investigators is leaving the University.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: LS301 Dose Level 1 (0.05 mg/kg) | Experimental |
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| Phase I: LS301 Dose Level 2 (0.075 mg/kg) | Experimental |
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| Phase I: LS301 Dose Level 3 (0.1 mg/kg) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LS301 | Drug | -LS301 is produced at the Optical Radiology Laboratory at Washington University School of Medicine |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient |
| From time of injection to 1 hour post-injection |
| Phase I only: Optimal imaging dose of LS301 |
| From time of injection to 1 hour post-injection |
| Phase II only: Ability of LS301 to predict presence of positive margins |
| At the time of pathological analysis (within 2-3 days of surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan C Fields, M.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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.
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The operating surgeon will remain blinded to the fluorescence images throughout the operation.
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| Phase II: LS301 Dose determined in Phase I | Experimental |
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| Cancer Vision Goggles | Device | -Non-significant risk device |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |