Overview

This trial is active, not recruiting.

Conditions glioblastoma, brain metastases
Treatment nm404
Phase phase 1/phase 2
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date December 2011
End date January 2017
Trial size 19 participants
Trial identifier NCT01516905, 1R01CA158800-01, RO11310

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404
nm404 PET imaging with I-124 NM404
injection of either 2.0mCi or 5.0mCi I-124 NM404

Primary Outcomes

Measure
tumor to background ratios
time frame: 48hrs

Eligibility Criteria

Male or female participants at least 18 years old.

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 -

Additional Information

Official title PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404
Principal investigator Lance Hall, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.