NCT03387410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

December 18, 2017

Last Update Submit

November 16, 2018

Conditions

Ureter Injury

Keywords

Laparoscopic surgeryFluorescence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of adverse events related to IRDye 800BK administration

    30 days post administration

Study Arms (1)

Intravenous IRDye 800BK

EXPERIMENTAL

Patients undergoing laparoscopic bowel resection \& laparoscopic donor nephrectomy

Drug: Intravenous IRDye 800BK

Interventions

Intravenous IRDye 800BKDRUG

Fluorescence of the ureter using IRDye 800BK

Intravenous IRDye 800BK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 2, 2018

Study Start

April 6, 2018

Primary Completion

November 1, 2018

Study Completion

November 16, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)