Silica Nanoparticles for Head and Neck Cancer Imaging

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByHilda Stambuk, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new dye-labeled particle to help doctors see cancerous lymph nodes during surgery in patients with head and neck cancer. The particles are injected around the tumor and light up under a special camera, making it easier to identify affected areas. This method aims to improve current imaging techniques by using recent innovations in imaging technology.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My melanoma diagnosis was confirmed through tissue examination at MSKCC.

I was recently diagnosed and had a lump removed for testing.

I still have visible tumor signs after initial treatment.

I need flap reconstruction in my head or neck after previous cancer treatments.

Participant Groups

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.

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.