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PET Imaging for Melanoma

N/A

Waitlist Available

Led By Michelle Bradbury, MD,PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed patients with previous excisional biopsy

18 years of age or older

Must not have

Inability to lie in the scanner for 30 minutes

Abnormal thyroid function, such as untreated clinical diagnosis of hypothyroidism, hyperthyroidism, or other thyroid disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the investigational particle can help find cancer in people who have already had a CAT scan or MRI that showed possible cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an imaging study using a tracer particle and not a drug treatment trial per se, specific side effects are not detailed but could include reactions related to the injection such as pain or swelling at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I've had treatment or surgery in my head/neck and need flap reconstruction.

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I have a new or returning melanoma or brain tumor with visible signs of the tumor.

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I have been cancer-free from any cancer other than melanoma or brain tumor for over 5 years.

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My melanoma or brain tumor diagnosis was confirmed through tissue analysis at MSKCC.

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My heart is healthy based on my last check-up.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stay still in a scanner for 30 minutes.

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I have an untreated thyroid condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†

Secondary study objectives

Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: newly diagnosed or recurrent head/neck melanomaExperimental Treatment1 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.

0 / 9Eligibility criteria met