Clinical trial · Interventional

LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery

Evaluation of LS301 Uptake in Tumors of Patients Undergoing Liver, Pancreas, or Gastric Surgery

NCT04105062CI-TRIAL-00055444withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): One of the investigators is leaving the University.

Summary

Brief summary (as posted)

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

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Gastrointestinal Stromal Cancer	—	UNRESOLVED	—
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Metastatic Cancer	Malignant Neoplasm	CURATED_BROADER	0.78
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Cancer Vision Goggles	Device	—	UNRESOLVED
LS301	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Phase I: LS301 Dose Level 1 (0.05 mg/kg)
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.
interventionNames
1. Drug: LS301
2. Device: Cancer Vision Goggles
type
EXPERIMENTAL
label
Phase I: LS301 Dose Level 2 (0.075 mg/kg)
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.