Status:
ACTIVE_NOT_RECRUITING
PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Newly Diagnosed or Recurrent Metastatic Melanoma Patients
Malignant Brain Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01266096
Start Date
January 1 2011
End Date
December 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065