Validation of ICG to Identify the Urethra During Rectal Surgery

NCT03204201 | Terminated Phase 1

• 1 other identifier: 12748
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

Conditions

Urethra Injury; Rectal Cancer; Surgery

Keywords

Fluorescence

Outcome Measures

Primary Outcomes (1)

• Number of urethras identified under white light and fluorescence

  1 day

Secondary Outcomes (4)

• Signal to background ratios between cohorts of patients with varying doses of ICG

  1 day

• Subjective assessment of usefulness of technology during operative procedure

  1 day

• Length of time of interruption in operative procedure to perform trial intervention

  1 day

• Number of adverse events related to trial intervention

  30 days

Study Arms (1)

Urethral instillation of ICG

EXPERIMENTAL

Urethral instillation of indocyanine green (ICG)

Drug: Indocyanine Green Solution

Interventions

Indocyanine Green Solution DRUG

Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant

Urethral instillation of ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male, aged 18 years or above.
• Undergoing low rectal surgery where the operating field will be close to the urethra

You may not qualify if:

• Participant has an allergy to iodine or ICG
• Known liver failure

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Oxford: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Roel Hompes, MD

  Consultant Colorectal Surgeon

  PRINCIPAL INVESTIGATOR

• Thomas Barnes, MBChB

  Clinical Research Fellow

  PRINCIPAL INVESTIGATOR

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: June 28, 2017
• First Posted: June 29, 2017
• Study Start: July 11, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)