Silica Nanoparticles for Head and Neck Cancer Imaging

Not currently 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

Disqualifiers: Pregnancy, Breast-feeding, Uncontrolled infection, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to help surgeons identify cancerous lymph nodes during head and neck cancer surgeries. Researchers are testing whether a special dye (cRGDY-PEG-Cy5.5-C dots, a type of silica nanoparticle), injected around the tumor, can make these nodes visible with a handheld camera. This method will not alter the treatment but might aid in designing better cancer detection techniques in the future. Individuals with head and neck cancer preparing for surgery might find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to experience this innovative approach.

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 prior data suggests that this imaging technique is safe for head and neck cancer patients?

Research has shown that cRGDY-PEG-Cy5.5-C dots, a new type of imaging agent, have been tested in humans before. These tiny particles help doctors visualize cancerous lymph nodes during surgery. In earlier studies, patients did not report serious side effects after receiving these particles, and they are generally well-tolerated. They are used with surgery to enhance imaging, not to treat cancer.

Since this study is in its early stages, researchers are primarily focused on safety. So far, the treatment appears safe enough to continue testing in humans. However, as the study is ongoing, more information is needed to fully confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for head and neck cancer, which typically involves surgery, radiation, and chemotherapy, cRGDY-PEG-Cy5.5-C dots offer a new imaging approach. This treatment uses silica nanoparticles to provide highly detailed images of cancerous tissues. Researchers are excited because these nanoparticles can be injected around the tumor and light up under certain conditions, helping to identify cancerous lymph nodes during surgery. This could potentially lead to more precise surgeries and better outcomes, as surgeons can visually distinguish between cancerous and non-cancerous tissues.

What evidence suggests that cRGDY-PEG-Cy5.5-C dots are effective for imaging head and neck cancer?

Research has shown that cRGDY-PEG-Cy5.5-C dots, a type of tiny silica particle, are safe for the body and do not harm living tissue. In this trial, participants with head and neck cancer will receive a locally-administered, peritumoral injection of these particles to help surgeons identify cancerous lymph nodes during surgery. These particles illuminate areas that might contain cancer when viewed with a special camera. An earlier study successfully used similar particles to map lymph nodes in patients with melanoma, a type of skin cancer. This evidence suggests that cRGDY-PEG-Cy5.5-C dots could aid in detecting cancerous lymph nodes during head and neck cancer surgeries. ^{1 2 3 6 7}

Who Is on the Research Team?

Hilda Stambuk, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02106598

NCT02106598 | Targeted Silica Nanoparticles for Real- ... This is a Phase II study, containing a total of 67 patients with head and neck cancer. The purpose of this study is to test if imaging, with cRGDY-PEG-Cy5.5-C ...

2. withpower.com withpower.com/trial/phase-2-melanoma-3-2014-ed908

Silica Nanoparticles for Head and Neck Cancer Imaging 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7974643/

Use of Ultrasmall Core-Shell Fluorescent Silica ... In this study, we present the results of a phase 1/2a particle-driven SLN mapping trial in patients with head and neck melanoma, an orphan ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4428677/

Clinically-translated silica nanoparticles as dual-modality ... We evaluated the feasibility of using 124I-cRGDY-PEG-C dots and combined PET-optical imaging approaches for SLN mapping in a spontaneous melanoma miniswine ...

5. clinconnect.io clinconnect.io/trials/NCT02106598

Targeted Silica Nanoparticles for Real-Time Image-Guided The researchers want to see if a special dye-labeled particle, called cRGDY-PEG-Cy5.5-C dots, can help surgeons find cancerous lymph nodes during surgery.

6. clinicaltrial.be clinicaltrial.be/en/details/74851?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Targeted Silica Nanoparticles for Real-Time Image-Guided... The purpose of this study is to test if imaging, with cRGDY-PEG-Cy5.5-C dots is useful for evaluating your type of cancer. This is currently not ...

7. wires.onlinelibrary.wiley.com wires.onlinelibrary.wiley.com/doi/10.1002/wnan.1624

Image‐guided tumor surgery: The emerging role of ... Finally, the silica-based 124I-cRGDY-PEG-Cornell dots (C dots) containing Cy5 were administered to patients with metastatic melanoma in a first- ...