This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
94
intravenous injection of IS-001 investigational drug
no drug injection
George Washington University Hospital
Washington D.C., District of Columbia, United States
St.David's Medical Center
Austin, Texas, United States
Las Palmas Medical Center
El Paso, Texas, United States
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 10 minutes
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 30 minutes
Evaluate fluorescent intensity of ureter by signal to background analysis
Fluorescent intensity of ureter evaluated as signal to background
Time frame: 60 minutes
Safety 12-Lead EKG Change from Baseline
12-Lead EKG change from baseline in QTc
Time frame: 6 hours
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Time frame: 24 hours
Incidence of abnormal blood work in tests results
Safety hematology complete blood count laboratory assessments Change from Baseline
Time frame: 14 days
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
Time frame: 24 hours
Incidence of abnormal blood work in tests results
Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline
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Time frame: 14 days
Incidence of abnormal urinalysis results
Routine urinalysis laboratory assessment change from baseline
Time frame: 14 days
Safety Adverse Events Monitoring
Drug related adverse events monitoring through 14-days
Time frame: 14 days
Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels
Maximal concentration of investigational drug-plasma levels (Cmax)
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast)
Area under the plasma curve from t(0) to last plasma sample
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf)
Area under the plasma curve from t(0) extrapolated to infinity
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Drug Plasma Clearance (CL)
Clearance of the investigational drug from plasma
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Terminal Elimination Half-life (t1/2)
Half-life of the investigational drug in plasma
Time frame: 0, 1-2 hours and 2-3 hours
Pharmacokinetics Apparent Volume of Distribution (Vz)
The apparent volume of distribution of the investigational drug
Time frame: 0, 1-2 hours and 2-3 hours
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes
Time frame: 10 minutes
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes
Time frame: 30 minutes
Ureter Identification Efficacy on a Nominal Scale
Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes.
Time frame: 60 minutes
Ureter Delineation Efficacy as Length of Line Drawn in Millimeters
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Time frame: 10 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Time frame: 30 minutes
Ureter Delineation Efficacy as Length of Line Drawn
Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.
Time frame: 60 minutes
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Time frame: 10 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Time frame: 30 minutes post-dose
Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale
Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.
Time frame: 60 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.
Time frame: 10 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points
Time frame: 30 minutes post-dose
Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale
Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.
Time frame: 60 minutes post-dose