PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-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 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

Official Title
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PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404

Conditions
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Glioblastoma Multiforme, Brain Metastases

Intervention / Treatment
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* Drug: NM404
* 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 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.

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I124-NM404 brain metastases or GBM imaging<br>injection of I-124NM404 for imaging | Drug: NM404<br>* injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404<br>Drug: NM404<br>* injection of an experimental imaging agent, 5mCi I-124NM404<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake | TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection. | 24- and 48 hours post injection | 
| Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors | TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection. | 24- and 48 hours post injection | 
| Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake | Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection. | 24- and 48 hours post injection | 
| Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors | Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection. | 24- and 48 hours post injection |