NCT02106598Active, not recruitingPhase 1/2
Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 3 Apr 2014
- Start date
- 3 Apr 2014
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT02106598
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 67
- From 3 Apr 2014 to the primary completion date, 30 Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Known pregnancy or breast-feeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.