Glowing dots could help surgeons spot hidden cancer during surgery
NCT ID NCT02106598
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tests a new dye, called cRGDY-PEG-Cy5.5-C dots, to help surgeons see cancer in lymph nodes during head and neck melanoma surgery. About 67 people will receive the dye injection around their tumor before or during surgery. The dye is not a treatment, but may improve how doctors find cancerous lymph nodes in real time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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67 people
The number who actually took part.
- Started
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Apr 2014
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Weill Cornell Medical Center
New York, New York, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A prospective imaging study of target definition and radiation planning workflows on the integrated TrueBeam-HyperSight system for patients receiving radiation therapy
- Can a Self-Care program ease Post-Cancer swelling in the head and neck?
- Blood biomarkers may foreshadow Radiation-Induced dry mouth
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can a smart breathing device make life with a tracheostomy more comfortable?
- A simple dye might replace radioactive tracers in cancer staging