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

Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The "RED-GREEN-BLUE" melanoma study. - Feasibility of indocyanine green in sentinel node biopsy in melanoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002244-25-GB

Enrollment

Registered

2012-06-12

Start date

2012-07-05

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: ICG-PULSION Product Name: Indocyanine Green Product Code: PICG0050UK Pharmaceutical Form: Powder for injection INN or Propos

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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; Timepoint(s) of evaluation of this end point: Peri-operative evaluation. No follow-up required. Single intra-operative injection.	—

Measure

Time frame

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; Timepoint(s) of evaluation of this end point: Peri-operative evaluation. No follow-up required. Single intra-operative injection.

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Secondary

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

Countries

United Kingdom

Contacts

Public ContactMoncrieff

Norfolk & Norwich University Hospital Foundation NHS Trust

marc.moncrieff@nnuh.nhs.uk00441603288127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026