ymphatic mapping for sentinel node identificatio

Phase 1

• Conditions: 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); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000424-18-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-20
• Study Completion: 2015-10-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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 <110 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified