PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404

Last updated: November 14, 2019
Sponsor: University of Wisconsin, Madison
Overall Status: Completed

Phase

N/A

Condition

Astrocytoma

Brain Metastases

Gliomas

Treatment

N/A

Clinical Study ID

NCT01540513
RO11360
SMPH\RADIOLOGY\RADIOLOGY
A539300
2011-0830
NCI-2012-02080
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants will have a contrast enhanced brain MRI which documents evidence ofprimary 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 obtainedwithin 2 months of study inclusion

  • Adult patients 18 or older

  • Female patients must not be pregnant or breast feeding and both women of childbearingpotential, and men, must use appropriate means of contraception and must be maintainedfor at least 45 days after injection of 124I-NM404 Participants must not attempt tobecome 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 ≤ 100U/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) musthave concluded ≥2 months prior to injection of 124I-NM404

Exclusion

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 eachover 3 days

  • Pregnancy or breast-feeding during time of study and/or anticipated breast feeding atany time for 45 days after injection of 124I-NM404.

Study Design

Total Participants: 12
Study Start date:
March 01, 2012
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

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