Study Summary
This trial is testing if injecting a dye-labeled particle can help visualize cancerous lymph nodes in head and neck cancer patients. This is to improve upon the current standard of care scans.
Eligible Conditions
- Head and Neck Melanoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 1 year
1 year
feasibility of conducting pre-operative SLN mapping
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Phase 2 - Head and Neck Cancer
1 of 1
Experimental Treatment
86 Total Participants · 1 Treatment Group
Primary Treatment: fluorescent cRGDY-PEG-Cy5.5-C dots · No Placebo Group · Phase 1 & 2
Phase 2 - Head and Neck Cancer
Drug
Experimental Group · 1 Intervention: fluorescent cRGDY-PEG-Cy5.5-C dots · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,389 Total Patients Enrolled
Hilda Stambuk, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For melanoma patients, if patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.
You have a newly-diagnosed or recurrent malignant melanoma, oral cavity squamous cell carcinoma, or squamous cell carcinoma of the skin patient in whom SLN mapping is indicated.
The tumor must be clinically or radiographically evident.
You have had prior radiation therapy, chemotherapy, or surgery in the head and neck region.
The patient must be in good health and free of cardiac disease.
ANC > 1000/mcl and platelets > 100,000/mcl.
Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
References
- Zanoni, Daniella Karassawa, Hilda E. Stambuk, Brian Madajewski, Pablo H. Montero, Danielli Matsuura, Klaus J. Busam, Kai Ma, et al.. 2021. “Use of Ultrasmall Core-shell Fluorescent Silica Nanoparticles for Image-guided Sentinel Lymph Node Biopsy in Head and Neck Melanoma”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.1936.
- 2014. "Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02106598.
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Conditions
Cancer Related
Treatments