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NCT02106598 · ClinicalTrials.gov registry record · Phase 1
Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
A Phase 1 study of Head and Neck Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 2
- Study locations
NCT02106598: Active Phase 1 study of Head and Neck Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02106598 is a Phase 1 study of Head and Neck Melanoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02106598, a Phase 1 study of Head and Neck Melanoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG fluorescent cRGDY-PEG-Cy5.5-C dots
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2014-04-03 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What the registry record for NCT02106598 still lists
NCT02106598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Head and Neck Melanoma appearing as the primary indexed condition, and to 1 intervention - of which fluorescent cRGDY-PEG-Cy5.5-C dots is the first listed.
NCT02106598 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02106598 about?
NCT02106598 is a clinical study titled "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...
What is the current status of trial NCT02106598?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2014-04-03. Estimated completion is 2026-04.
What conditions does trial NCT02106598 study?
This clinical trial studies the following conditions: Head and Neck Melanoma.
What interventions are being tested in trial NCT02106598?
The interventions under investigation include: fluorescent cRGDY-PEG-Cy5.5-C dots (DRUG).
Who is sponsoring clinical trial NCT02106598?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02106598 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02106598's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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