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Completed

NCT Number: NCT03387410

Ureter Identification With IRDye 800BK

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous IRDye 800BK

Drug

Fluorescence of the ureter using IRDye 800BK

Primary outcomes

  1. Change of signal to background measurements and visualisation of fluorescence in the ureter

    Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose

    Signal to background is an objective measurement of fluorescence signal

  2. Change in subjective assessment of ureter visualisation with and without fluorescence

    Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose

Secondary outcomes

  1. Number of adverse events related to IRDye 800BK administration

    Time frame: 30 days post administration

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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