Clinical trial · Interventional
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
NCT06666634CI-TRIAL-00119016NANOSCANcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan
- description
- The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care.
- interventionNames
- Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Primary outcomes (1)
- measure
- Concordance between tracers
- timeFrame
- Measured at pre-operative imaging
- description
- To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who will undergo a sentinel node procedure in routine care. * Patients \> 18 years; * Patients presenting with: * a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities; * OR patients presenting with a primary oral cavity malignancy T1-2N0 * OR patients with primary penile cancer * Patients with clinical N0 stage; * Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion; * Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting Exclusion Criteria: * Patients with known allergy to patent blue dye or nanocolloid; * Patients who are pregnant or breast-feeding mothers; * History of hypersensitivity reactions to products containing human serum albumin; * History of iodine allergy * Hyperthyroid or thyroidal adenoma * Kidney insufficiency * Incapacity or unwillingness of participant to give written informed consent;
References
Publications (0)
Data not yet available
No reference posted for this study.