Ureter Identification With IRDye 800BK

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

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.

Study Overview

• Status: Completed
• Conditions: Ureter Injury
• Intervention / Treatment: Drug: Intravenous IRDye 800BK

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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	Time Frame
Number of adverse events related to IRDye 800BK administration	30 days post administration

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: University of Oxford

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2018
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 16, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Fluorescence
• Other Study ID Numbers: 12932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No