Silica Nanoparticles for Head and Neck Cancer Imaging

Recruiting at 1 trial location

Overseen By Snehal Patel, MD, FRCS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

67 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment cRGDY-PEG-Cy5.5-C dots for head and neck cancer imaging?

Research on similar silica nanoparticles shows they can enhance tumor imaging by specifically binding to cancer cells, which helps in better defining tumor borders during surgery. ^{1 2 3 4 5}

Is the use of silica nanoparticles for imaging in head and neck cancer safe for humans?

Research on silica nanoparticles, including cRGDY-PEG-Cy5-C dots, shows they have good biocompatibility (they are not harmful to living tissue) and have been safely used in studies for imaging and targeting cancer cells. These studies suggest that they are generally safe for use in humans, although more research is needed to confirm this across different conditions. ^{1 2 3 6 7}

How do silica nanoparticles differ from other treatments for head and neck cancer?

Silica nanoparticles are unique because they are designed to improve cancer imaging by enhancing tumor border definition during surgery, using fluorescent dyes and antibodies to target specific cancer cells. This approach differs from traditional treatments by focusing on precise imaging rather than directly treating the cancer, potentially leading to more accurate surgical outcomes. ^{1 2 4 8 9}

Research Team

Hilda Stambuk, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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

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.

Exclusion Criteria

Known pregnancy or breast-feeding

I do not have severe health issues that would prevent me from taking the treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Imaging

Participants undergo imaging of lymph nodes prior to surgery using standard of care methods

1 day

1 visit (in-person)

Intraoperative Imaging

Participants receive a peritumoral injection of cRGDY-PEG-Cy5.5-C dots for real-time image-guided mapping of nodal metastases during surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure

4 weeks

Treatment Details

Interventions

• cRGDY-PEG-Cy5.5-C dots

Trial Overview 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.

Participant Groups

Group I: Phase 2 - Head and Neck Cancer Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Silica nanoparticles, specifically Ru@SiO2-OH and Ru@SiO2-NH2, showed long-term intracellular persistence in head and neck squamous cell carcinoma (HNSCC) cells without affecting cell proliferation or morphology, suggesting potential for chronic therapeutic applications.

The study indicates that these nanoparticles are internalized through specific pathways and accumulate in organelles, but further research is needed to understand their complex endocytotic mechanisms and optimize their use in HNSCC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and fate of surface modified silica nanoparticles in head and neck squamous cell carcinoma. Besic Gyenge, E., Darphin, X., Wirth, A., et al.[2021]

Ultra-small NaYF4:Nd3+/NaGdF4 nanocrystals coated with manganese dioxide (usNP-MnO2) show promise for improving oxygen levels in head and neck squamous cell carcinomas (HNSCC) by modulating tumor hypoxia.

The study utilized dual modality imaging (MRI and photoacoustic imaging) to successfully visualize nanoparticle delivery and increased oxygen saturation in tumor models, indicating a potential method for selecting patients who could benefit from these hypoxia-modifying therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic and Magnetic Resonance Imaging of Hybrid Manganese Dioxide-Coated Ultra-small NaGdF4 Nanoparticles for Spatiotemporal Modulation of Hypoxia in Head and Neck Cancer. Rich, LJ., Damasco, JA., Bulmahn, JC., et al.[2021]

The study demonstrated that 100 nm theranostic nanoparticles can enhance radiation therapy for head and neck squamous cell carcinoma, showing reduced tumor growth and lung metastasis in rat models.

These nanoparticles provide both imaging capabilities and therapeutic benefits, allowing for better radiation therapy planning and improved treatment efficacy, as evidenced by their optimal tumor uptake and effectiveness in reducing tumor size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

X-ray and MR Contrast Bearing Nanoparticles Enhance the Therapeutic Response of Image-Guided Radiation Therapy for Oral Cancer. Sharma, G., Razeghi Kondelaji, MH., Sharma, GP., et al.[2023]

The study developed a new imaging technique using dual-modal near-infrared II (NIR II) luminescence and T1 magnetic resonance imaging (MRI) that targets the cMet receptor, which is overexpressed in head and neck squamous cell carcinomas (HNSCCs).

This innovative approach allows for better visualization and accumulation of imaging agents in HNSCC tumors, potentially leading to more accurate and sensitive early detection of this common cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Met-Targeted Dual-Modal MRI/NIR II Imaging for Specific Recognition of Head and Neck Squamous Cell Carcinoma. Wu, J., Liu, J., Lin, B., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fluorescein- and EGFR-Antibody Conjugated Silica Nanoparticles for Enhancement of Real-time Tumor Border Definition Using Confocal Laser Endomicroscopy in Squamous Cell Carcinoma of the Head and Neck. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Uptake and fate of surface modified silica nanoparticles in head and neck squamous cell carcinoma. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Photoacoustic and Magnetic Resonance Imaging of Hybrid Manganese Dioxide-Coated Ultra-small NaGdF4 Nanoparticles for Spatiotemporal Modulation of Hypoxia in Head and Neck Cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Cisplatin-conjugated gold nanoparticles as a theranostic agent for head and neck cancer. [2019]

5. Singapore pubmed.ncbi.nlm.nih.gov

Advances in nanomedicine for head and neck cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

X-ray and MR Contrast Bearing Nanoparticles Enhance the Therapeutic Response of Image-Guided Radiation Therapy for Oral Cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cancer-Targeting Ultrasmall Silica Nanoparticles for Clinical Translation: Physicochemical Structure and Biological Property Correlations. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Met-Targeted Dual-Modal MRI/NIR II Imaging for Specific Recognition of Head and Neck Squamous Cell Carcinoma. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[In situ visual imaging and in vivo distribution of head and neck squamous cell carcinoma in mice by near-infrared fluorescent quantum dots epidermal growth factor receptor monoclonal antibody probe]. [2019]