Ureter Identification With IRDye 800BK

Study Overview
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Brief Summary
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Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.

Official Title
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Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery

Conditions
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Ureter Injury

Intervention / Treatment
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* Drug: Intravenous IRDye 800BK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Group A & B participants) Participant is willing and able to give informed consent for participation in the trial. Male or Female, aged 18 years or above. Undergoing elective laparoscopic abdominal surgery or undergoing planned laparoscopic donor nephrectomy (donation) Participant has available laboratory and ECG results within 3 months of enrolment. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter In the Investigator's opinion, is able and willing to comply with all trial requirements. Group A only: Participant is undergoing laparoscopic colorectal surgery Group B only: Participant is undergoing laparoscopic donor nephrectomy Exclusion Criteria (Group A & B participants) The participant may not enter the trial if ANY of the following apply: Female participant who is pregnant, lactating or planning pregnancy throughout the trial. Significant renal impairment (eGFR of under 50mL/min/1,73m2) Significant liver impairment as defined as: AST > 3.0 x ULN or ALT > 3.0 x ULN or Total serum bilirubin > 1.5 x ULN Participants involved with another research trial involving an unlicensed medicine in the past 12 weeks. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Known allergy to D-Mannitol or citric acid Group B Only: Laparoscopic donor nephrectomy patients in whom the kidney recipient has refused participation or if the recipient is being transplanted in another transplant centre Inclusion criteria for transplant recipients Participant must be willing and able to give informed consent for trial participation Male or female aged 18 years or over Is able and willing to comply with all trial requirements Receiving a kidney from a participant recruited to this study Exclusion criteria for transplant recipients • Female who is pregnant, lactating, or planning pregnancy throughout the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous IRDye 800BK<br>Patients undergoing laparoscopic bowel resection & laparoscopic donor nephrectomy | Drug: Intravenous IRDye 800BK<br>* Fluorescence of the ureter using IRDye 800BK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of signal to background measurements and visualisation of fluorescence in the ureter | Signal to background is an objective measurement of fluorescence signal | 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose | 
| Change in subjective assessment of ureter visualisation with and without fluorescence |  | 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events related to IRDye 800BK administration |  | 30 days post administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic surgery, Fluorescence