PET Imaging for Melanoma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use special dyes that are injected into a vein and can better localize possible cancer. The investigators have developed a new particle that can carry a radioactive dye to a very specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas of possible disease. This particle has been studied in mice and was safe. The particles will not treat the 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.

Research Team

Hilda Stambuk, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of melanoma or malignant brain tumor at MSKCC, who may have had prior treatments like surgery, chemo, or radiation. They must be able to use birth control and not have other recent cancers (except the one being studied), uncontrolled illnesses, severe heart disease, thyroid dysfunction, allergies to iodine contrast material, weigh over 400 lbs., or suffer from claustrophobia.

Inclusion Criteria

I was recently diagnosed and had a lump removed for testing.

I am 18 years old or older.

All patients of childbearing and child-creating age must be using an acceptable form of birth control

Exclusion Criteria

I cannot stay still in a scanner for 30 minutes.

I do not have severe health issues that would prevent me from receiving the tracer.

I have had cancer other than melanoma or brain cancer, but have been disease-free for less than 5 years.

Treatment Details

Interventions

• 124I-cRGDY-PEG-dots (Imaging Agent)

Trial Overview The study tests a new PET scan dye carried by nanoparticles designed to target cancer areas more precisely than current imaging methods. This microdosing study aims to see how well the dye works in humans after being proven safe in mice. It's important to note that this particle won't treat cancer; it's purely for improving detection.

Participant Groups

Group I: newly diagnosed or recurrent head/neck melanoma Experimental Treatment 1 Intervention

This is a two-year microdosing study that will enroll 5 metastatic melanoma patients and 18 malignant brain tumor patients (surgical (n=13) and non-surgical candidates (n=5)). We have already accrued 5 melanoma patients and expect to accrue brain tumor patients within a 1 year period.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+