Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue (TRIUMPh)

A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue fluoroPhore

This is a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Feasibility of urine sample collection during surgery will also be assessed.

Study Overview

• Status: Recruiting
• Conditions: Fluorescence Guided Surgery
• Intervention / Treatment: Device: Methylene blue fluorescence

Detailed Description

Background - During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If the ureters are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the National Health Service. Even experienced surgeons are at risk of causing this dreaded complication.

Methylene blue can emit a fluorescent signal and highlight the ureters in real time during surgical procedures. A study is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery.

Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log. Included patients with receive intraoperative methylene blue injection in increasing doses. Urine samples will be taken to establish the conversion of methylene blue to leucomethylene blue.

Expected results - the investigators expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment. Secondary outcomes are ureteric identification and conversion of methylene blue to leucomethylene blue.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Pampiglione; Phone Number: 02034567890; Email: tom.pampiglione@nhs.net
• Study Contact Backup: Name: UCLH JRO; Phone Number: 02034567890; Email: uclh.randd@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London Hospital

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:

• 18 years of age or older
• Scheduled for a surgery where routine ureter identification is used
• Have signed an approved informed consent form for the study
• Be willing and able to comply with the study protocol

Exclusion Criteria:

• Known allergy or history of adverse reaction to methylene blue
• Taking an antidepressant including, but not limited, to selective and non-selective serotonin reuptake inhibitors, or a psychiatric medication
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Renal dysfunction defined as estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2
• Has participated in another investigational study within 30 days prior to surgery
• Pregnant or lactating subjects
• Subjects who, in the Investigator's and/or designee's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methyl Blue; This group will receive intraoperative IV methyl blue	Device: Methylene blue fluorescence; IV administration of methylene blue, detection with deep infrared camera and light source

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recruitment to study	Feasibility of recruitment to the study. This will be recorded in the screening log. The number of patients able partake in the study will be expressed as a percentage of the number of patients approached for consent. Patients will be excluded if the do not meet the inclusion/exclusion criteria or do not consent.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ureteric identification and signal intensity at defined time points	The operation will be paused and image switched to the Pinpoint camera at 5, 10, 15, 20, 30 and 40 minutes. The signal to background ratio will be calculated from the near infra-red images. This will allow us to quantify the fluorescence of methylene blue under near infra-red light.	12 months
Percentage conversion of methylene blue to leucomethylene blue at defined time points	Urine samples will be taken at 10 minute intervals after the administration of methyl blue. The ratio of methylene blue to leucomethylene blue will be calculated at each of these stages to determine the likely rate of conversion rate.	12 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals
• Investigators: Principal Investigator: Manish Chand, PhD, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: 120726

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