PET Imaging for Melanoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Thyroid disease, Pregnancy, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is 124I-cRGDY-PEG-dots safe for use in humans?

In a clinical trial with patients having metastatic melanoma, the 124I-cRGDY-PEG-C dot particles were found to be well-tolerated with no toxic or adverse events observed. The particles showed stable behavior in the body and were safely excreted through the kidneys. ^{1 2 3 4 5}

How does PET imaging for melanoma differ from other treatments?

PET imaging for melanoma is unique because it uses specialized radiotracers, like 18F-PEG3-FPN, to detect melanoma metastases with high precision, particularly in the liver and lungs, while minimizing liver uptake. This approach allows for better visualization of cancer spread compared to traditional imaging methods. ^{2 4 6 7 8}

Who Is on the Research Team?

Hilda Stambuk, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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

If you are a woman who has not gone through menopause, you need to have a negative pregnancy test.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdosing Study

Participants receive a microdose of 124I-labeled cRGDY silica nanomolecular particle tracer for PET imaging to study biodistribution, pharmacokinetics, and metabolic stability

2 years

Follow-up

Participants are monitored for safety and radiation dosimetry after tracer administration

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 124I-cRGDY-PEG-dots

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.

How Is the Trial Designed?

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+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Synthesis and comparative in vivo evaluation of 99m Tc(CO)3 -labeled PEGylated and non-PEGylated cRGDfK peptide monomers. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

PET Imaging of VLA-4 in a New BRAFV600E Mouse Model of Melanoma. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Synthesis and characterization of a novel radioiodinated phenylacetamide and its homolog as theranostic agents for malignant melanoma. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical translation of an ultrasmall inorganic optical-PET imaging nanoparticle probe. [2022]

5. England pubmed.ncbi.nlm.nih.gov

PEGylation enhances the tumor selectivity of melanoma-targeted conjugates. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of 2-[18F]-2-deoxy-D-glucose positron emission tomography in staging of regional lymph nodes in patients with cutaneous malignant melanoma. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Improved detection of regional melanoma metastasis using 18F-6-fluoro-N-[2-(diethylamino)ethyl] pyridine-3-carboxamide, a melanin-specific PET probe, by perilesional administration. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Synthesis and Preclinical Evaluation of 18F-PEG3-FPN for the Detection of Metastatic Pigmented Melanoma. [2018]