A feasibility study to assess the accuracy of indocyanine green in the identification of sentinel lymph nodes for patients with cutaneous melanoma

Phase 1

• Conditions: Cutaneous Melanoma; MedDRA version: 20.0 Level: LLT Classification code 10025655 Term: Malignant melanoma of skin System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10068478 Term: Sentinel lymphadenectomy System Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2012-002244-25-GB
• Lead Sponsor: orfolk & Norwich University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Any patients eligible for Sentinel lymph node biopsy for cutaneous melanoma
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Patients unable to give informed consent.
2. Patients with reduced mental capacity to give informed consent.
3. Vulnerable adults, children, prisoners.
4. Patients who already have undergone lymph node dissection in a potentially draining lymph node field.
5. Patients where the preoperative lymphoscintigraphy has failed.
6. Patients who are allergic to indocyanine green
7. Pregnant or lactating women
8. Patients with hyperthyroidism or with toxic thyroid adenomas
9. Palpable lymph nodes in draining regional nodal field

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal research question is to assess the sensitivity of indocyanine green (ICG) for Sentinel lymph node detection in cutaneous melanoma in combination with technetium radio­isotope and patent blue dye.;Secondary Objective: A secondary aim of this study is to evaluate the new technique in comparison with our previous experience of technetium in combination with patent blue dye, in particular length of time of sentinel node surgery and perioperative morbidity.;Primary end point(s): Accuracy of indocyanine green identifying the Sentinel lymph node;<br> Timepoint(s) of evaluation of this end point: Peri-operative evaluation.<br> No follow-up required.<br> Single intra-operative injection.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Length of time to perform the procedure.<br> Perioperative complication rate<br> ;<br> Timepoint(s) of evaluation of this end point: Peri-operative evaluation.<br> No follow-up required.<br> Single intra-operative injection.<br>