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Phase 1/Phase 2
18 Years
Open (Enrolling)
Glioblastoma, Brain Metastases

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Trial Information

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 -

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

tumor to background ratios

Outcome Description:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Lance Hall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Hospital and Clinics


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

January 2017

Related Keywords:

  • Glioblastoma
  • Brain Metastases
  • Glioblastoma
  • Neoplasm Metastasis
  • Brain Neoplasms



University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001