Bowel cancer MedDRA version: 14.1 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ICG-Pulsion
Product Name: Indocyanine Green (ICG)
Product Code: N/A
Pharmaceutical Form: Powder for injection
INN or Propose
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine whether the first (sentinel) lymph nodes in the drainage pathway of a 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) into the colon adjacent to the tumour. The dye will then be seen as it fluoresces in the light from 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 and 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 w;Secondary Objective: • 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) • To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: As it is a feasibility study and we are recruiting a small number of patients, evaluation of data will not commence untill the last patient has undergone surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Sensitivity and specificity of tumour-bearing status of SLN(s) as a measure of lymph node status when assessed by standard techniques. • Frequency and tumour-bearing status of aberrant SLN(s);Timepoint(s) of evaluation of this end point: As it is a feasibility study and we are recruiting a small number of patients, evaluation of data will not commence untill the last patient has undergone surgery. | — |
Countries
United Kingdom
Contacts
Public ContactMiss Adela Brigic
St. Mark's Hospital and Academic Institute, North West London Hospitals Trust
Outcome results
None listed