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Lymphatic Mapping for Sentinel Node Identification and Analysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662752
First Posted: August 10, 2012
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
London North West Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer Drug: Indocyanine green Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Assess Near Infrared Laparoscopy With Indocyanine Green (ICG) for Intraoperative Lymphatic Imaging and Sentinel Lymph Node Identification During Standard Surgical Resection for Colonic Cancer

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • The proportion of subjects in which the SLN(s) are identified [ Time Frame: 12 months ]
    To establish whether it is possible to identify the first order draining mesocolic lymph nodes (sentinel lymph node(s) (SLNs) in patients with suspected T1 and T2 colonic cancer, using ICG, a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system


Secondary Outcome Measures:
  • Sensitivity and specificity of tumour-bearing status of SLN(s) as a measure of lymph node status when assessed by standard techniques [ Time Frame: 12 ]
    To assess the extent to which that the tumour-bearing status of SLN(s) identified corresponds with lymph node status as assessed by standard methods (pathological examination of excised nodes using H&E and immunohistochemistry)


Other Outcome Measures:
  • Frequency and tumour-bearing status of aberrant SLN(s [ Time Frame: 12 ]
    To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field


Enrollment: 30
Study Start Date: May 2013
Study Completion Date: October 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Indocyanine green
Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging
Drug: Indocyanine green
Please see arm description

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients willing and able to give informed consent for participation in the study
  2. Patients willing and able to comply with the study procedures
  3. Male or Female, aged 18 years or above
  4. Patients diagnosed with T1 or T2 colonic neoplasia on preoperative staging and require laparoscopic surgical excision
  5. If female, a negative pregnancy test for women of childbearing potential prior to surgery
  6. Patients who have clinically acceptable laboratory results pre-operatively with serum creatinine of <110 mg/dL

Exclusion Criteria:

  1. Patients diagnosed with T3 or T4 disease on preoperative imaging
  2. A patient who is pregnant, lactating or planning pregnancy during the course of the study
  3. Allergy to any of the compounds being used for lymphatic mapping including Indocyanine green or sodium iodide
  4. Patients with hyperthyroidism or those with thyroid adenomas
  5. Patients with renal insufficiency (serum creatinine of >110 mg/dL)
  6. Patients in whom the use of ICG is contraindicated including development of adverse events when previously or presently administered
  7. Previous allergic reaction to shellfish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662752


Locations
United Kingdom
North West London Hospital
London, UK, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Imperial College London
London North West Healthcare NHS Trust
Investigators
Principal Investigator: Robin Kennedy, FRCS, MS Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01662752     History of Changes
Other Study ID Numbers: C/32/2012
First Submitted: August 7, 2012
First Posted: August 10, 2012
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Imperial College London:
Early colonic cancer
Sentinel lymph node mapping
Sentinel lymph node biopsy
Near infrared imaging
Indocyanine green
Laparoscopic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases