Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases

Current imaging devices usually detect cancer prior to surgery. However, these devices cannot be used during the surgical procedure to visualize lymph nodes with cancer (called "sentinel lymph nodes"). 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 dots is useful for evaluating your type of cancer. This is currently not approved by the FDA. The researchers want to see if cRGDY-PEG-Cy5.5-C dots, can improve upon the usual scans. As a part of your standard of care, you will initially undergo imaging of your lymph nodes prior to your surgery. Prior to your surgery, you will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours later using a device to image the location of the dye. We have tested, for the first time in humans, a new, experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. This particle, the size of a small protein, will be injected around sites of your tumor before or during your surgery to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. The particles will not treat your cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Melanoma
• Intervention / Treatment: Drug: fluorescent cRGDY-PEG-Cy5.5-C dots

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States
      • Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Histologically confirmed diagnosis of melanoma at MSKCC
• Have one of the following disease histories:

• Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, oral cavity squamous cell carcinoma, and squamous cell carcinoma of the skin patients in whom SLN mapping is indicated

  • Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas
  • Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
  • Newly diagnosed patients with previous excisional biopsy.
• At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
• At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.
• At the discretion of the physician or surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
• For melanoma patients, if patients have a history of malignancy other than melanoma, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.
• All patients of childbearing and child-creating age must be using an acceptable form of birth control
• Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria:

• Known pregnancy or breast-feeding.
• Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Phase 2 - Head and Neck Cancer; 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.

Drug: fluorescent cRGDY-PEG-Cy5.5-C dots

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of conducting pre-operative SLN mapping	using real-time optical detection procedures and intradermal single- or double-dose injection/s of non-radioactive cRGDY-PEG-Cy5.5-C dots about the primary tumor site. Feasibility will be determined on the basis of achieving adequate image contrast for detection, as defined by signal-to-background ratios, and whether optical signal distinguishes diseased SLNs from non-diseased ones	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Hilda Stambuk, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Zanoni DK, Stambuk HE, Madajewski B, Montero PH, Matsuura D, Busam KJ, Ma K, Turker MZ, Sequeira S, Gonen M, Zanzonico P, Wiesner U, Bradbury MS, Patel SG. Use of Ultrasmall Core-Shell Fluorescent Silica Nanoparticles for Image-Guided Sentinel Lymph Node Biopsy in Head and Neck Melanoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e211936. doi: 10.1001/jamanetworkopen.2021.1936.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2014
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimated): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sentinel Lymph Node Mapping; Intraoperative Sentinel; Head and Neck Melanoma; Targeted Silica Nanoparticles; cRGDY-PEG-Cy5.5-C dots; 13-249
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: 13-249