PET/CT Imaging of Malignant Brain Tumors With 124I-NM404

Study Overview
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Brief Summary
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The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI findings with pathological specimens, which is the gold standard but is invasive and impractical in many cases, to determine the sensitivity and specificity of both techniques for accurately detecting tumor infiltration. The data obtained from this study will be used to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404.

Official Title
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PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404

Conditions
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Glioblastoma, Brain Metastases

Intervention / Treatment
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* Drug: NM404


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will have a contrast enhanced brain MRI which documents evidence of GBM or metastatic brain tumor Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion 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 I-124 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 Karnofsky score ≥ 60 For brain metastases patients: targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404 For GBM tumors confirmed by surgical biopsy or suspected by MRI: no previous surgical resection (except for biopsy) or systemic or radiation therapy targeted to the GBM tumor - Exclusion Criteria: Life expectancy of < 3 months Allergy to potassium iodide (SSKI or Thyroshield) Planned surgical resection or biopsy after injection of 124I-NM404 and prior to completion of the 3rd PET/CT scan Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I124-NM404 brain metastases or GBM imaging<br>determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404 | Drug: NM404<br>* injection of either 2.0mCi or 5.0mCi I-124 NM404<br>* Other names: PET imaging with I-124 NM404;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor to background ratios | patients will be imaged at 3 different times out to 48 hrs post injection. Images will be evaluated based on tumor/background, dimensions/volumes and a qualitative score | 48hrs |