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Silica Nanoparticles for Head and Neck Cancer Imaging

Phase 1 & 2
Waitlist Available
Led By Hilda Stambuk, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Histologically confirmed diagnosis of melanoma at MSKCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Who is the study for?
This trial is for adults with newly diagnosed or recurrent melanoma, oral cavity squamous cell carcinoma, and skin squamous cell carcinoma needing lymph node mapping. Participants must use birth control if applicable and have normal organ function as determined by the physician. Those who've had recent heart issues, uncontrolled infections, or are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests a new imaging agent called cRGDY-PEG-Cy5.5-C dots in 67 patients to see if it can better identify cancerous lymph nodes during surgery compared to standard scans. This agent isn't FDA-approved yet and won't be used for treatment but may inform future research.See study design
What are the potential side effects?
Since this is an investigational imaging agent not intended for treatment, specific side effects aren't detailed here; however, potential risks could include allergic reactions to the dye or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My melanoma diagnosis was confirmed through tissue examination at MSKCC.
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I was recently diagnosed and had a lump removed for testing.
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My heart is healthy according to my doctor's evaluation.
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I still have visible tumor signs after initial treatment.
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I need flap reconstruction in my head or neck after previous cancer treatments.
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I have been diagnosed with melanoma or squamous cell carcinoma and need SLN mapping.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
feasibility of conducting pre-operative SLN mapping

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 2 - Head and Neck CancerExperimental Treatment1 Intervention
Patients with early oral cavity squamous cell carcinoma, and prior to standard of care wide local resection of the primary tumor and elective neck dissection, will receive a locally-administered, peritumoral injection of fluorescent cRGDY-PEG-Cy5.5-C dots (0.25 - 1 ml) around the primary lesion while under standard-of-care anesthesia for identification of optically-avid SLNs and to assess for metastatic disease. After completion of the neck dissection, nodal specimens will be examined ex vivo for fluorescence signal. Any fluorescent and non-fluorescent nodes will be compared to determine the true positive and false positive rates for cancer detection in this pilot study. No change in standard of care surgical practice will occur.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,741 Total Patients Enrolled
76 Trials studying Melanoma
15,911 Patients Enrolled for Melanoma
Hilda Stambuk, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Melanoma
10 Patients Enrolled for Melanoma

Media Library

fluorescent cRGDY-PEG-Cy5.5-C dots Clinical Trial Eligibility Overview. Trial Name: NCT02106598 — Phase 1 & 2
Melanoma Research Study Groups: Phase 2 - Head and Neck Cancer
Melanoma Clinical Trial 2023: fluorescent cRGDY-PEG-Cy5.5-C dots Highlights & Side Effects. Trial Name: NCT02106598 — Phase 1 & 2
fluorescent cRGDY-PEG-Cy5.5-C dots 2023 Treatment Timeline for Medical Study. Trial Name: NCT02106598 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to this research experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this research endeavour is actively recruiting participants. It was originally put up for public viewing on April 3rd 2014 and last modified on November 23rd 2022; it requires 86 individuals from two separate sites."

Answered by AI

Is this research endeavor currently seeking participants?

"According to clinicaltrials.gov, this medical trial is accepting participants. First posted on April 3rd 2014 and last edited November 23rd 2022, potential volunteers are encouraged to apply."

Answered by AI
~0 spots leftby Apr 2024