Head and Neck MelanomaPhase 1/2NCT02106598
Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
A Phase 1/2 study testing fluorescent cRGDY-PEG-Cy5.5-C dots in people with Head and Neck Melanoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Melanoma
- What is being tested?
- fluorescent cRGDY-PEG-Cy5.5-C dots
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2014to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York
About this study
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
- Being tested
- fluorescent cRGDY-PEG-Cy5.5-C dots
- Keywords
- Sentinel Lymph Node Mapping, Intraoperative Sentinel, Head and Neck Melanoma, Targeted Silica Nanoparticles, cRGDY-PEG-Cy5.5-C dots, 13-249
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescent cRGDY-PEG-Cy5.5-C dotsDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 - Head and Neck Cancer | Experimental | 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. Receives: Drug: fluorescent cRGDY-PEG-Cy5.5-C dots |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start3 Apr 2014
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilda Stambuk, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106598
- Sponsor's protocol ID
- 13-249
- Status last verified
- May 2026
- First submitted
- 3 Apr 2014
- Last updated
- 6 May 2026
- Results posted
- No
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.
PubMed 33734415
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
- ClinicalTrials.gov ID
- NCT02106598
- Acronym / sponsor ID
- 13-249
- Conditions
- Head and Neck Melanoma
- Keywords
- Sentinel Lymph Node Mapping, Intraoperative Sentinel, Head and Neck Melanoma, Targeted Silica Nanoparticles, cRGDY-PEG-Cy5.5-C dots, 13-249
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 2 - Head and Neck Cancer | Experimental | Drug: fluorescent cRGDY-PEG-Cy5.5-C dotsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescent cRGDY-PEG-Cy5.5-C dots | Drug | Phase 2 - Head and Neck Cancer |
Primary outcome
feasibility of conducting pre-operative SLN mapping
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 33734415Zanoni 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilda Stambuk, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fluorescent cRGDY-PEG-Cy5.5-C dots in people with Head and Neck Melanoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of conducting pre-operative SLN mapping (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02106598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.