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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06666634
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Netherlands Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Penile Cancer, Melanoma, Oral Cancer
Additional Details

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.#46; 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.

Arms & Interventions

Arms

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.

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

NKI-AVL, Amsterdam 2759794, Netherlands

Status

Recruiting

Address

NKI-AVL

Amsterdam 2759794, ,

Site Contact

Oscar Dr. O. Brouwer

[email protected]

+31205129111

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