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PET Imaging for Melanoma
New York, NY
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.
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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.Check my eligibility
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.See study design
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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot stay still in a scanner for 30 minutes.
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I have an untreated thyroid condition.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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.
Find a Location
Closest Location:Memorial Sloan Kettering Cancer Center· New York, NY
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,996 Previous Clinical Trials
602,335 Total Patients Enrolled
78 Trials studying Melanoma
16,416 Patients Enrolled for Melanoma
Michelle Bradbury, MD,PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Hilda Stambuk, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Melanoma
67 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was recently diagnosed and had a lump removed for testing.I cannot stay still in a scanner for 30 minutes.I am 18 years old or older.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.You have had an allergic reaction to a contrast material containing iodine.If you are a woman who has not gone through menopause, you need to have a negative pregnancy test.You are afraid of being in tight spaces.I've had treatment or surgery in my head/neck and need flap reconstruction.You weigh more than 400 pounds, which is too heavy for the PET scanner.The doctor decides if your white blood cell count and platelet count are high enough.Your bilirubin level should be below 2.0 mg/dl, and you shouldn't have a history of a specific liver condition called Gilbert's disease.I have a new or returning melanoma or brain tumor with visible signs of the tumor.I have an untreated thyroid condition.I have been cancer-free from any cancer other than melanoma or brain tumor for over 5 years.My melanoma or brain tumor diagnosis was confirmed through tissue analysis at MSKCC.My heart is healthy based on my last check-up.
Research Study Groups:
This trial has the following groups:- Group 1: newly diagnosed or recurrent head/neck melanoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.