Clinical trial NCT01266096: PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Official title: PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Newly Diagnosed or Recurrent Metastatic Melanoma Patients
Malignant Brain Tumors
Keywords: 124I-cRGDY-PEG-dots
Pet scan
10-155
melanoma
brain
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†
timeFrame: 2 years
Secondary outcomes:
measure: Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots.
timeFrame: 1 year
measure: Assay particle tracer tissue distributions in tumor tissue specimens
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hilda Stambuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.