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Lymphatic Mapping for Sentinel Node Identification and Analysis

NCT01662752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-09

Study results available
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Summary

The main objective of this study is to determine whether the first (sentinel) lymph nodes in the drainage pathway of colonic tumour can be detected at the time of surgery using a new technique. The detection method is to inject a fluorescent dye (indocyanine green) adjacent to the tumour. The dye will then be seen as it fluoresces in the light form the near infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected around the tumour. The mesentery in which the lymph nodes draining the tumour are located will then be examined by laparoscopy as it is expected that fluorescence will be identified within approximately 5 minutes of the injection. The first lymph node or nodes that take up the fluorescent dye will then be marked by placing a clip or a stitch by them. After the surgery has been completed and colon removed all lymph nodes can be examined microscopically by the pathologist, paying a particular attention to whether any tumour cells are present in the sentinel lymph nodes and whether the presence or the absence of tumour cells in that node accurately reflects the tumour status of the rest of the specimen.

If this pilot demonstrates that sentinel lymph nodes can be reliably detected, we have developed a technique which allows us to remove a small area (less than 5 cm) of the colon. Using this procedure should decrease complications following traditional surgery. We however also need a method that allows accurate assessment of the lymph nodes draining the tumour. This pilot trial will examine our ability to detect such 'sentinel' lymph nodes so that we can use their status (positive for cancer cells or negative) to determine whether a smaller operation such as full thickness localised excision is adequate treatment for the patient and that they can avoid a larger operation.

Conditions

Interventions

DRUG

Indocyanine green

Please see arm description

Sponsors & Collaborators

  • London North West Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Robin Kennedy, FRCS, MS · Imperial College London

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662752 on ClinicalTrials.gov