Clinical trial NCT04105062: LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Official title: Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Liver Cancer
Gastric Cancer
Gastrointestinal Stromal Cancer
Metastatic Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Phase I only: Safety of LS301 as measured by incidence of related adverse events per patient
timeFrame: From time of injection to 1 hour post-injection
measure: Phase I only: Optimal imaging dose of LS301
timeFrame: From time of injection to 1 hour post-injection
measure: Phase II only: Ability of LS301 to predict presence of positive margins
timeFrame: At the time of pathological analysis (within 2-3 days of surgery)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Ryan C Fields, M.D.
role: PRINCIPAL_INVESTIGATOR
References: