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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting melanoma (a type of skin cancer) and brain tumors using special PET scans. These scans employ a new particle, 124I-cRGDY-PEG-dots, which carries a radioactive dye to help doctors identify potential cancer locations. The trial aims to enhance future cancer detection and research, not to treat cancer. Individuals newly diagnosed with melanoma or a malignant brain tumor, or those with a recurrence, may qualify. Participants should have visible tumors and may have previously undergone treatments like surgery or chemotherapy. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in cancer detection.

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.

What prior data suggests that this PET imaging method is safe for detecting melanoma?

Research has shown that the treatment using 124I-cRGDY-PEG-dots has been tested for safety in animals. Studies found that this tiny particle did not harm mice. In another study, similar particles were safely used in animals like pigs to aid imaging in melanoma cases. This suggests the treatment is likely safe for PET scans in humans.

Additionally, research on other types of tiny particles demonstrated their safety for imaging in head and neck melanoma. Although the treatment is still in early testing stages for humans, these findings provide some reassurance about its safety. However, careful monitoring remains essential to ensure the safety of all participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 124I-cRGDY-PEG-dots for melanoma because it offers a new way to visualize cancer using PET imaging. Unlike traditional treatments that focus on directly attacking the cancer cells, this approach involves a radiolabeled probe that specifically targets integrins, which are proteins often overexpressed in cancer cells. This targeting allows doctors to see the precise location and extent of the cancer, potentially leading to more personalized and effective treatment plans. Additionally, the microdosing aspect of this approach minimizes exposure to radiation, making it safer for patients.

What evidence suggests that this PET imaging method is effective for detecting melanoma?

Research has shown that 124I-cRGDY-PEG-dots, a new type of particle studied in this trial, can detect melanoma more accurately. Studies have found that these particles, when used with PET scans, excel at identifying cancer that has spread in the body. This method uses a special dye that adheres to tumors, enhancing their visibility in scans. In animal tests, these particles safely identified cancer areas with high accuracy. Although this treatment does not cure cancer, it helps doctors pinpoint the cancer's location, which is crucial for planning future treatments. ^{1 2 4 6 7}

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.

You have had an allergic reaction to a contrast material containing iodine.

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4428677/

Clinically-translated silica nanoparticles as dual-modality ... We evaluated the feasibility of using 124I-cRGDY-PEG-C dots and combined PET-optical imaging approaches for SLN mapping in a spontaneous melanoma miniswine ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01266096

Study Details | NCT01266096 | PET Imaging of Patients ... We have already accrued 5 melanoma patients and expect to accrue brain tumor patients within a 1 year period. Intervention/Treatment, Drug : PET scan with 124I- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3223837/

Multimodal silica nanoparticles are effective cancer ... Locally injected 124I-cRGDY-PEG-dot tracer and dynamic PET imaging enabled superior detection sensitivity and discrimination of metastatic tumor burden ...

4. science.org science.org/doi/10.1126/sciadv.aax5208

Molecular phenotyping and image-guided surgical ... ... head and neck melanoma using cRGDY-Cy5.5-PEG-C′ dots (NCT02106598 ... Radiolabeling of cRGDY-PEG-CW800-C′ dots with 124I was performed ...

5. bradburylab.weill.cornell.edu bradburylab.weill.cornell.edu/research

Research Favorable PET pharmacokinetic data is shown over time using a novel 124I-labeled integrin-targeting particle platform, 124I-cRGDY-PEG-Cy5-C' dots, that was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7974643/

Use of Ultrasmall Core-Shell Fluorescent Silica ... This study found that nanoparticle-based fluorescence-guided SLN biopsy in head and neck melanoma was feasible and safe. This technology holds ...

7. jci.org jci.org/articles/view/45600

Multimodal silica nanoparticles are effective cancer ... Locally injected 124I-cRGDY-PEG-dot tracer and dynamic PET imaging enabled superior detection sensitivity and discrimination of metastatic tumor burden within ...