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Lymphatic Mapping for Sentinel Node Identification and Analysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Imperial College London
Sponsor:
Collaborator:
London North West Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01662752
First received: August 7, 2012
Last updated: March 27, 2013
Last verified: March 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662752

Contacts
Contact: Andrew Currie, MBChB, MRCS +44 208 235 4225 slnmcc@imperial.ac.uk
Contact: Robin Kennedy, FRCS, MS +44 208 235 4108 robin.kennedy@nhs.net

Locations
United Kingdom
North West London Hospital Not yet recruiting
London, UK, United Kingdom, HA1 3UJ
Contact: Andrew Currie, MBChB, MRCS    +44 208 869 5289    slnmcc@imperial.ac.uk   
Contact: Robin Kennedy, FRCS, MS    +44 208 235 4108    robin.kennedy@nhs.net   
Sponsors and Collaborators
Imperial College London
London North West Healthcare NHS Trust
Investigators
Principal Investigator: Robin Kennedy, FRCS, MS Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01662752     History of Changes
Other Study ID Numbers: C/32/2012
Study First Received: August 7, 2012
Last Updated: March 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014