LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery
Status and phase
Withdrawn
Phase 2
Phase 1
Conditions
Metastatic Cancer
Gastric Cancer
Liver Cancer
Gastrointestinal Stromal Cancer
Pancreatic Cancer
Treatments
Device: Cancer Vision Goggles
Drug: LS301
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Diagnostic
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
Single Blind
0 participants in 4 patient groups
Phase I: LS301 Dose Level 1 (0.05 mg/kg)
Experimental group
Description:
* 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.
Treatment:
Device: Cancer Vision Goggles
Drug: LS301
Phase I: LS301 Dose Level 2 (0.075 mg/kg)
Experimental group
Description:
* 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.
Treatment:
Device: Cancer Vision Goggles
Drug: LS301
Phase I: LS301 Dose Level 3 (0.1 mg/kg)
Experimental group
Description:
* 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.
Treatment:
Device: Cancer Vision Goggles
Drug: LS301
Phase II: LS301 Dose determined in Phase I
Experimental group
Description:
* 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.
Treatment:
Device: Cancer Vision Goggles
Drug: LS301
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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