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Ureter Identification With IRDye 800BK

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ClinicalTrials.gov Identifier: NCT03387410
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Thomas Barnes, Oxford University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Ureter Injury Drug: Intravenous IRDye 800BK Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 16, 2018

Arm Intervention/treatment
Experimental: Intravenous IRDye 800BK
Patients undergoing laparoscopic bowel resection & laparoscopic donor nephrectomy
Drug: Intravenous IRDye 800BK
Fluorescence of the ureter using IRDye 800BK




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of adverse events related to IRDye 800BK administration [ Time Frame: 30 days post administration ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387410


Locations
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
University of Oxford

Responsible Party: Thomas Barnes, Clinical Research Fellow, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03387410     History of Changes
Other Study ID Numbers: 12932
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Barnes, Oxford University Hospitals NHS Trust:
Laparoscopic surgery
Fluorescence