Lymphatic Mapping for Sentinel Node Identification and Analysis

NCT01662752 | Completed Phase 2 Results DMC

• 1 other identifier: C/32/2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Keywords

Early colonic cancer; Sentinel lymph node mapping; Sentinel lymph node biopsy; Near infrared imaging; Indocyanine green; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Subjects in Which the SLN(s) Are Identified

  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 Indocyanine Green (ICG), a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system

  28 days

Secondary Outcomes (1)

• Sensitivity and Specificity of Tumour-bearing Status of SLN(s) as a Measure of Lymph Node Status When Assessed by Standard Techniques

  28 days

Other Outcomes (1)

• Frequency and Tumour-bearing Status of Aberrant SLN(s

  28 days

Study Arms (1)

Indocyanine green

OTHER

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

Interventions

Indocyanine green DRUG

Please see arm description

Indocyanine green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients diagnosed with T3 or T4 disease on preoperative imaging
• A patient who is pregnant, lactating or planning pregnancy during the course of the study
• Allergy to any of the compounds being used for lymphatic mapping including Indocyanine green or sodium iodide
• Patients with hyperthyroidism or those with thyroid adenomas
• Patients with renal insufficiency (serum creatinine of \>110 mg/dL)
• Patients in whom the use of ICG is contraindicated including development of adverse events when previously or presently administered
• Previous allergic reaction to shellfish

Sponsors & Collaborators

• Imperial College London: lead
• London North West Healthcare NHS Trust: collaborator

Study Sites (1)

North West London Hospital

London, UK, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• Currie AC, Brigic A, Thomas-Gibson S, Suzuki N, Moorghen M, Jenkins JT, Faiz OD, Kennedy RH. A pilot study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative sentinel lymph node mapping in early colon cancer. Eur J Surg Oncol. 2017 Nov;43(11):2044-2051. doi: 10.1016/j.ejso.2017.05.026. Epub 2017 Aug 23.

  PMID: 28919031 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor Robin Kennedy
• Organization: St Mark's Hospital

robin.kennedy@nhs.net

+44(0)2082354046

Study Officials

• Robin Kennedy, FRCS, MS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 10, 2012
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)