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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 belowSelect...
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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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,844 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not have severe health issues that would prevent me from taking the treatment.My melanoma diagnosis was confirmed through tissue examination at MSKCC.I was recently diagnosed and had a lump removed for testing.My heart is healthy according to my doctor's evaluation.Your white blood cell count and platelet count are high enough as decided by the surgeon.Your bilirubin level should be lower than 2.0 mg/dl, unless your doctor thinks it's okay due to a condition called Gilbert's disease.Women who have not gone through menopause need to have a negative blood pregnancy test.I still have visible tumor signs after initial treatment.I need flap reconstruction in my head or neck after previous cancer treatments.I have been diagnosed with melanoma or squamous cell carcinoma and need SLN mapping.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 - Head and Neck Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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