ear-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
Completed
- Conditions
- lymph nodesentinel node1002765510043413
- Registration Number
- NL-OMON52846
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
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.
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The intraoperative detection of SLNs in paediatric patients who received a<br /><br>pre-operative injection of ICG-99mTc-nanocolloid without blue dye. This is<br /><br>called detection rate, which is the percentage of patients in which the SLN is<br /><br>detected using ICG. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Evaluation of NIR fluorescence for the SLN procedure by the surgeon by means<br /><br>of a short questionnaire;<br /><br>2. Correlation between NIR fluorescent and radioactive SLNs;<br /><br>3. Number of failures to find the preoperatively detected SLN;<br /><br>4. Tumor to background ratio;<br /><br>5. The safety of using a pre-operative injection of ICG-99mTc-nanocolloid for<br /><br>the SLN procedure in paediatric patients.</p><br>