View Clinical Trial (Medical Research Study)
PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Newly Diagnosed or Recurrent Metastatic Melanoma Patients - Malignant Brain Tumors |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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 EKG and pre-operative evaluation
- ANC>1000/mcl and platelets>100,000/mcl.
- 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 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:
- 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 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
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| NCT ID: |
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NCT01266096 |
| Primary Contact: |
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Principal Investigator
Michelle Bradbury, MD,PhD
Memorial Sloan-Kettering Cancer Center
Michelle Bradbury, MD, PhD
Phone: 646-888-3373
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| Backup Contact: |
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Snehal Patel, MD
Phone: 212-639-3412
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| Location Contact: |
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New York, New York 10065
United States
Michelle Bradbury, MD, PhD
Phone: 212-639-8938
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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