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

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma; Brain Metastases
• Intervention / Treatment: Drug: NM404

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; injection of either 2.0mCi or 5.0mCi I-124 NM404; Other Names: PET imaging with I-124 NM404

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48hrs

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lance Hall, MD, University of Wisconsin, Madison; Principal Investigator: Scott Perlman, MD, MS, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): May 17, 2016
• Study Completion (Actual): May 17, 2016

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioblastoma; Brain Neoplasms
• Other Study ID Numbers: RO11310; A539300 (Other Identifier: UW Madison); SMPH\RADIOLOGY\RADIOLOGY (Other Identifier: UW Madison); 1R01CA158800-01 (U.S. NIH Grant/Contract); NCI-2012-02042 (Registry Identifier: NCI Trial ID); 2011-0452 (Other Identifier: Institutional Review Board)