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CompletedNCT01516905Updated Nov 15, 2019

PET/CT Imaging of Malignant Brain Tumors With 124I-NM404

An observational study in Glioblastoma and Brain Metastases, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-15.

Sponsored by University of Wisconsin, Madison · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Glioblastoma
  • Brain Metastases
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 19 is below the median of 60 across 188 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be recruited when seen by oncologists in the UWCCC clinic.

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

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 -
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Groups and cohorts

  • I124-NM404 brain metastases or GBM imaging

    determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404

    Drug: NM404

Interventions

  • DrugNM404

    injection of either 2.0mCi or 5.0mCi I-124 NM404

    Also known as: PET imaging with I-124 NM404

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What researchers measure

Primary outcomes

  1. tumor to background ratios

    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

    Time frame: 48hrs

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Study locations

1 site
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01516905
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 25, 2012
Start date
Dec 2011
Primary completion
May 17, 2016
Completion
May 17, 2016
Last update
Nov 15, 2019

Study contacts

Lance Hall, MD
principal investigator · University of Wisconsin, Madison
Scott Perlman, MD, MS
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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