PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Newly Diagnosed or Recurrent Metastatic Melanoma Patients; Malignant Brain Tumors
• Intervention / Treatment: Drug: PET scan with 124I-cRGDY-PEG-dots

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Histologically confirmed diagnosis of melanoma or malignant brain tumor at MSKCC
• Newly-diagnosed or recurrent (local,regional, metastatic) metastatic melanoma or malignant brain tumor patients with
• Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas or malignant brain tumor
• Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
• Newly diagnosed patients with previous excisional biopsy.
• Normal baseline cardiac function based upon pre-operative evaluation
• At the discretion of the physician ANC>1000/mcl and platelets>100,000/mcl.
• At the discretion of the physician Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
• If patients have a history of malignancy other than melanoma or malignant brain tumor they must be disease-free (excluding primary cancer for metastatic patients) for ≥ 5 years at the time of enrollment.
• All patients of childbearing and child-creating age must be using an acceptable form of birth control
• Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria:

• Abnormal thyroid function, such as untreated clinical diagnosis of hypothyroidism, hyperthyroidism, or other thyroid disease
• Known pregnancy or breast-feeding.
• Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the tracer. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.
• History of any malignancy (excluding primary cancer for metastatic patients) other than melanoma or malignant brain tumors for which the disease-free interval is <5 years.
• Allergic reaction to iodine-containing contrast material
• Weight greater than the 400-lb weight limit of the PET scanner
• Claustrophobia
• Inability to lie in the scanner for 30 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: newly diagnosed or recurrent head/neck melanoma; 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.

Drug: PET scan with 124I-cRGDY-PEG-dots; Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†	in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots.	studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects	1 year
Assay particle tracer tissue distributions in tumor tissue specimens		2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Hilda Stambuk, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Phillips E, Penate-Medina O, Zanzonico PB, Carvajal RD, Mohan P, Ye Y, Humm J, Gonen M, Kalaigian H, Schoder H, Strauss HW, Larson SM, Wiesner U, Bradbury MS. Clinical translation of an ultrasmall inorganic optical-PET imaging nanoparticle probe. Sci Transl Med. 2014 Oct 29;6(260):260ra149. doi: 10.1126/scitranslmed.3009524. Epub 2014 Oct 29.

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimated): December 24, 2010

Study Record Updates

• Last Update Posted (Estimated): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: brain; melanoma; Pet scan; 124I-cRGDY-PEG-dots; 10-155
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 10-155