NCT01266096Active, not recruiting
PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 21 Dec 2010
- Start date
- Jan 2011
- Primary completion date
- Dec 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT01266096
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From Jan 2011 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Abnormal thyroid function, such as untreated clinical diagnosis of hypothyroidism, hyperthyroidism, or other thyroid disease
- 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.
- Allergic reaction to iodine-containing contrast material
Age
- 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.
Other
- Known pregnancy or breast-feeding.
- Weight greater than the 400-lb weight limit of the PET scanner
- Claustrophobia
- Inability to lie in the scanner for 30 minutes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.