Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01516905 : PET/CT Imaging of Malignant Brain Tumors With 124I-NM404
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
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 -
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01516905      |      Link to official Clinicaltrials.gov listing
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