Brain Metastases, Glioblastoma
Conditions
Brief summary
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.
Interventions
DRUGNM404
injection of either 2.0mCi or 5.0mCi I-124 NM404
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumor to background ratios | 48hrs | 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 |
Countries
United States
Outcome results
None listed