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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2012
End Date:October 2014

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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


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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