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PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01516905
First received: January 10, 2012
Last updated: June 18, 2013
Last verified: June 2013

January 10, 2012
June 18, 2013
January 2012
January 2017   (final data collection date for primary outcome measure)
tumor to background ratios [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
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
Determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, tumor dosimetry) of 124I-NM404 PET/CT in patients with brain metastasis [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
patients will be imaged at 3 different timepoints 6hrs,24 hrs and 48 hrs. Images will be evaluated based on tumor/background, dimensions/volumes and a qualitative score
Complete list of historical versions of study NCT01516905 on ClinicalTrials.gov Archive Site
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PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404
Not Provided

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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Glioblastoma
  • Brain Metastases
Drug: NM404
injection of either 2.0mCi or 5.0mCi I-124 NM404
Other Name: PET imaging with I-124 NM404
Experimental: 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
Intervention: 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
25
January 2017
January 2017   (final data collection date for primary outcome measure)

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 -
Both
18 Years and older
No
Contact: Diana D Trask, BS 608-263-9528 datrask@humonc.wisc.edu
United States
 
NCT01516905
RO11310, 1R01CA158800-01
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
National Cancer Institute (NCI)
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