Making use of a fluorescent dye, ICG, to improve sentinel lymph node procedure in pediatric patients

Near-infrared fluorescence imaging using indocyanine green as an adjunct to improve standard-of-care sentinel lymph node procedure in pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities: a feasibility trial - ICG to improve sentinel lymph node procedure in pediatric patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000509-96-NL

Enrollment

Registered

2020-04-15

Start date

2020-05-14

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Sentinel node procedure for pediatric patients with melanoma or sarcoma

Interventions

Trade Name: VERDYE Product Name: Indocyanine green Product Code: Indocyanine green Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities that have an indication for a sentinel node procedure. Age 0-18 years. Written informed consent from patient/parents/legal guardians, according to local law and regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 22 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Allergy to iodine 2 Hypersensitivity to ICG 3. Kidney insufficiency (eGFR<55) 4. Clinical manifest hyperthyroidism/ autonomous thyroid adenoma 5. Nanocolloid or shell fish allergy (same as in standard care: or Technetium-nanocolloid use)

Design outcomes

Primary

Measure	Time frame
Main Objective: The feasibility of using ICG for intraoperative optical guidance in order to detect the sentinel lymph nodes in paediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities.;Secondary Objective: 1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon; 2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs); 3. Number of failures to find the preoperatively detected SLNs; 4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs; 5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients. ;Primary end point(s): The intraoperative detection of SLNs in paediatric patients who received a pre-operative injection of ICG (in addition to 99mTc-nanocolloid) without blue dye. ;Timepoint(s) of evaluation of this end point: Intraoperative (fluorescent SLNs) and postoperative (pathological confirmation of SLNs)	—

Measure

Time frame

Main Objective: The feasibility of using ICG for intraoperative optical guidance in order to detect the sentinel lymph nodes in paediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities.;Secondary Objective: 1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon; 2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs); 3. Number of failures to find the preoperatively detected SLNs; 4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs; 5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients. ;Primary end point(s): The intraoperative detection of SLNs in paediatric patients who received a pre-operative injection of ICG (in addition to 99mTc-nanocolloid) without blue dye. ;Timepoint(s) of evaluation of this end point: Intraoperative (fluorescent SLNs) and postoperative (pathological confirmation of SLNs)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon; 2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs); 3. Number of failures to find the preoperatively detected SLNs; 4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs; 5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients. ;Timepoint(s) of evaluation of this end point: 1. Postoperatieve evaluation surgeon 2. Intra-operative measurements, post-operative analysis 3. Post-operative calculations 4. Post-operative post-processing of data 5. Up to 72 hours post injection ICG	—

Measure

Time frame

Secondary end point(s): 1. Surgical evaluation of fluorescent imaging, which will be measured by means of a short questionnaire tailored for the surgeon; 2. Correlation between near-infrared (NIR) fluorescent and radioactive sentinel lymph nodes (SLNs); 3. Number of failures to find the preoperatively detected SLNs; 4. Tumor to background ratio (tumor fluorescence divided by background fluorescence) of the SLNs; 5. The safety of using a pre-operative injection of ICG for the SLN procedure in paediatric patients. ;Timepoint(s) of evaluation of this end point: 1. Postoperatieve evaluation surgeon 2. Intra-operative measurements, post-operative analysis 3. Post-operative calculations 4. Post-operative post-processing of data 5. Up to 72 hours post injection ICG

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Countries

Netherlands

Contacts

Public ContactProfessor, surgeon

Princess Maxima Center for pediatric oncology

m.h.w.wijnen-5@prinsesmaximacentrum.nl

Outcome results

None listed

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