This trial is active, not recruiting.

Conditions glioblastoma multiforme, brain metastases
Treatments nm404
Sponsor University of Wisconsin, Madison
Start date March 2012
End date November 2014
Trial size 12 participants
Trial identifier NCT01540513, RO11360


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
injection of I-124NM404 for imaging
injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404
injection of an experimental imaging agent, 5mCi I-124NM404

Primary Outcomes

tumor-to-background ratios
time frame: 48hrs

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
Principal investigator Lance Hall, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.