Lymphatic Mapping for Sentinel Node Identification and Analysis
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Indocyanine green
Intervention description: Please see arm description
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early colonic cancer; Sentinel lymph node mapping; Sentinel lymph node biopsy; Near infrared imaging; Indocyanine green; Laparoscopic

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.
    

Eligibility 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