Ureter Identification With IRDye 800BK

Ureter Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387410
• Other study ID #: 12932
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 6, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: November 2018
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 16, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ureter Injury

Intervention

Drug:
• Intravenous IRDye 800BK
Fluorescence of the ureter using IRDye 800BK

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of adverse events related to IRDye 800BK administration		30 days post administration