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

NCT06666634 | Recruiting

• 1 other identifier: N21NAN
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Cancer; Melanoma; Oral Cancer

Keywords

Fluorescence; Radioactivity; Indocyanine green; Clinical node negative patients; Surgical staging

Outcome Measures

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.

  Measured at pre-operative imaging

Secondary Outcomes (3)

• Higher echelon nodes

  Measured at pre-operative imaging

• Concordance between intraoperative fluorescence and radioactive findings

  Measured at pre-operative imaging

• Concordance between intraoperative fluorescence and radioactive findings

  Measured at pre-operative imaging

Study Arms (1)

Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan

OTHER

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.

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

Interventions

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

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

Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

NKI-AVL

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Penile Neoplasms; Melanoma; Mouth Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Central Study Contacts

Oscar Brouwer, Dr.

CONTACT

0205129111; o.brouwer@nki.nl

Daphne Rietbergen, Dr.

CONTACT

0715269111; d.d.d.rietbergen@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: October 30, 2024
• Study Start: April 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)