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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:December 2011
End Date:May 17, 2016

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

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.


Inclusion Criteria:

1. Participants will have a contrast enhanced brain MRI which documents evidence of GBM
or metastatic brain tumor

2. Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained
within 2 months of study inclusion

3. 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

4. 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

5. Karnofsky score ≥ 60

6. For brain metastases patients: targeted brain therapy (radiation or drug) must have
concluded ≥2 months prior to injection of 124I-NM404

7. 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:

1. Life expectancy of < 3 months

2. Allergy to potassium iodide (SSKI or Thyroshield)

3. Planned surgical resection or biopsy after injection of 124I-NM404 and prior to
completion of the 3rd PET/CT scan

4. Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each
over 3 days -
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Lance Hall, MD
Phone: 608-263-9528
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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