Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
Patient who will undergo a sentinel node procedure in routine care.
Patients > 18 years;
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov