Validation of a new hybrid tracer for sentinel node biopsy in cancer patients
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
This study is testing a new hybrid tracer to see if it works as well as the current one for helping doctors find cancerous lymph nodes in patients with penile cancer, melanoma, and oral cancer during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06666634 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the use of ICG-99mTc-nanoscan as a hybrid tracer for sentinel node biopsy in patients with penile cancer, melanoma, and oral cancer. The investigators will compare the lymphatic drainage patterns and intraoperative signal intensities of ICG-99mTc-nanoscan with the established 99mTc-nanoscan. By ensuring that the new tracer maintains the same level of care as its predecessor, the study seeks to confirm its effectiveness in clinical settings. The trial will involve patients scheduled for sentinel node procedures as part of their routine care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with clinical N0 stage penile cancer, melanoma, or oral cavity malignancies scheduled for sentinel node biopsy.
Not a fit: Patients with known allergies to the study materials, pregnant or breastfeeding women, and those with certain medical conditions like kidney insufficiency will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and effectiveness of sentinel node biopsies, leading to better surgical outcomes for cancer patients.
How similar studies have performed: Previous studies have successfully validated similar hybrid tracers, indicating a promising approach for this new validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Amsterdam
- Nki-Avl — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Oscar Brouwer, Dr.
- Email: o.brouwer@nki.nl
- Phone: 0205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.