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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
NKI-AVL
RECRUITING
Amsterdam
Contact Information
Primary
Oscar Brouwer, Dr.
o.brouwer@nki.nl
0205129111
Backup
Daphne Rietbergen, Dr.
d.d.d.rietbergen@lumc.nl
0715269111
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 29
Treatments
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov