Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Concordance between tracers
Study Overview
Brief Summary
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.
Detailed Description
The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan
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.
Intervention: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan (Drug)
Outcomes
Primary Outcomes
Concordance between tracers
Time Frame: Measured at pre-operative imaging
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
- Concordance between intraoperative fluorescence and radioactive findings(Measured at pre-operative imaging)
- Higher echelon nodes(Measured at pre-operative imaging)