Clinical trial NCT03387410: Ureter Identification With IRDye 800BK
Official title: Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ureter Injury
Keywords: Laparoscopic surgery
Fluorescence
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2018-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of signal to background measurements and visualisation of fluorescence in the ureter
timeFrame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
measure: Change in subjective assessment of ureter visualisation with and without fluorescence
timeFrame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Secondary outcomes:
measure: Number of adverse events related to IRDye 800BK administration
timeFrame: 30 days post administration
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
References: