Fluorescence Targeted Pelvic Lymph Node Mapping

NCT03204994 | Terminated Phase 1

• 1 other identifier: 12451
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the lymphatic drainage of rectal tumours by using ICG as a fluorescent non-specific marker. As a feasibility study, it will also assess its technique and timing along with its ability to assist in removing lymph nodes when it is clinically indicated.

Conditions

Cancer of Rectum; Lymph Node Disease

Keywords

Colorectal surgery; Fluorescence guided surgery

Outcome Measures

Primary Outcomes (1)

• Number & location of lymph nodes identified with and without fluorescent probe during rectal cancer surgery

  1 day

Secondary Outcomes (2)

• Noise to background signal of lymph nodes compared with positivity of lymph nodes.

  1 day

• Number of lymph nodes lying outside the CRM identified by fluorescence

  1 day

Study Arms (1)

Tumour injection of ICG

EXPERIMENTAL

Indocyanine green injection into tumour before or during surgery.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

Fluorescence guided lymphatic mapping using indocyanine green.

Also known as: ICG

Tumour injection of ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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 or Female, aged 18 years or above.
• Participant is undergoing elective curative surgery for rectal adenocarcinoma
• Participant is willing and able to comply with study requirements

You may not qualify if:

• Participant has history of or known allergy to indocyanine green
• Participant has history of or known allergy to iodides
• Participant suffers from hyperthyroidism or has a benign thyroid tumour
• Participant has renal failure
• Female participant currently pregnant, planning pregnancy or breast feeding

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Indocyanine Green

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chris Cunningham, MD

  Chief Investigator

  PRINCIPAL INVESTIGATOR

• Thomas Barnes, MBChB

  Clinical Research Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• 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: July 2, 2017
• Study Start: August 1, 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)