View Clinical Trial (Medical Research Study)
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53792 |
| Conditions: |
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Glioblastoma Multiforme - Brain Metastases |
| Purpose: |
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The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404
PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and
determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating
tumor dosimetry. The long-term goals of this research are to improve the diagnosis and
treatment of malignant brain tumors by using radioiodinated NM404
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Participants will have a contrast enhanced brain MRI which documents
evidence of primary or metastatic brain tumor or suspected tumor recurrence after
therapy
- Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained
within 2 months of study inclusion
- Adult patients 18 or older
- Female patients must not be pregnant or breast feeding and both women of childbearing
potential, and men, must use appropriate means of contraception and must be
maintained for at least 45 days after injection of 124I-NM404 Participants must not
attempt to become pregnant during this time
- Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must
be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤
100 U/L, and urine or serum pregnancy test must be negative for pregnancy
- Patient provides informed consent
- Karnofsky score ≥ 60
- For previously treated brain tumors, targeted brain therapy (radiation or drug) must
have concluded ≥2 months prior to injection of 124I-NM404
Exclusion Criteria:
- Life expectancy of < 3 months
- Allergy to potassium iodide (SSKI or Thyroshield)
- Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each
over 3 days
- Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at
any time for 45 days after injection of 124I-NM404.
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| NCT ID: |
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NCT01540513 |
| Primary Contact: |
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Principal Investigator
Lance Hall, MD
University of Wisconsin Hospital and Clinics
Diana Trask, BS
Phone: 608-263-9528
Email: trask@humonc.wisc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Madison, Wisconsin 53792
United States
Diana Trask, BS
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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