PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study
This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01266096
First received: December 21, 2010
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Newly Diagnosed or Recurrent Metastatic Melanoma Patients Malignant Brain Tumors |
Drug: PET scan with 124I-cRGDY-PEG-dots |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PET Imaging of Patients With Melanoma and Malignant Brain Tumors Using an 124I-labeled cRGDY Silica Nanomolecular Particle Tracer: A Microdosing Study |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots† [ Time Frame: 2 years ] [ Designated as safety issue: No ]in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability.
Secondary Outcome Measures:
- Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots. [ Time Frame: 1 year ] [ Designated as safety issue: No ]studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects
- Assay particle tracer tissue distributions in tumor tissue specimens [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 11 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: newly diagnosed or recurrent head/neck melanoma
This is a two-year microdosing study that will enroll 5 metastatic melanoma and up patients to 6 brain tumor patients at MSKCC who have either have a high grade glioma (n=3) or brain metastases (n=3) from melanoma, non-small cell lung carcinoma, or other non-CNS primary lesion. 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 up to six (6) 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 GE STE PET/CT scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266096
Contacts
| Contact: Michelle Bradbury, MD, PhD | 646-888-3373 | |
| Contact: Snehal Patel, MD | 212-639-3412 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Michelle Bradbury, MD, PhD 646-888-3373 | |
| Principal Investigator: Michelle Bradbury, MD, PhD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Michelle Bradbury, MD,PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01266096 History of Changes |
| Other Study ID Numbers: | 10-155 |
| Study First Received: | December 21, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
124I-cRGDY-PEG-dots Pet scan 10-155 melanoma brain |
Additional relevant MeSH terms:
|
Brain Neoplasms Melanoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013