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

NCT02106598 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Head and Neck Melanoma

Interventions

DRUG

fluorescent cRGDY-PEG-Cy5.5-C dots

Sponsors & Collaborators

Principal Investigators

  • Hilda Stambuk, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-03
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02106598 on ClinicalTrials.gov