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Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy

ConditionsPenile CancerMelanomaOral Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

    Drug

    Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscanOther 1 intervention

Trial outcomes

Primary outcomes

1

Concordance between tracers

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.

Time frame
Measured at pre-operative imaging

Secondary outcomes

1

Higher echelon nodes

Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);

Time frame
Measured at pre-operative imaging
2

Concordance between intraoperative fluorescence and radioactive findings

Number of the fluorescent nodes at time of excision; \- Number and radioactive signal intensity of the radioactive nodes at time of excision;

Time frame
Measured at pre-operative imaging
3

Concordance between intraoperative fluorescence and radioactive findings

intensity of the fluorescent nodes at time of excision;

Time frame
Measured at pre-operative imaging

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Netherlands Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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