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

This study is currently recruiting participants.
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01540513
First received: February 14, 2012
Last updated: June 17, 2013
Last verified: June 2013

February 14, 2012
June 17, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
tumor-to-background ratios [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
imaging will be performed at 6hrs, 24hrs and 48 hrs post injection
Determine the optimal imaging parameters of 124I-NM404 PET/CT in patients with primary and metastatic brain tumors [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
imaging will be performed at 6hrs, 24hrs and 48 hrs post injection
Complete list of historical versions of study NCT01540513 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404

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

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Glioblastoma Multiforme
  • Brain Metastases
  • Drug: NM404

    injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging

    Other Names:

    PET imaging with I-124 NM404

  • Drug: NM404
    injection of an experimental imaging agent, 5mCi I-124NM404
Experimental: I124-NM404 brain metastases or GBM imaging
injection of I-124NM404 for imaging
Interventions:
  • Drug: NM404
  • Drug: NM404
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Diana Trask, BS 608-263-9528 trask@humonc.wisc.edu
United States
 
NCT01540513
RO11360
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Lance Hall, MD University of Wisconsin Hospital and Clinics
University of Wisconsin, Madison
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP