Glowing dots could help surgeons spot hidden cancer during surgery

NCT ID NCT02106598

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

67 people

The number who actually took part.

Started

Apr 2014

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head and neck cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • 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.