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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 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. The trial reports 2 study locations across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02106598
The ClinicalTrials.gov registry entry for NCT02106598 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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