Clinical trial NCT01540513: PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
Official title: PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Brain Metastases
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake
timeFrame: 24- and 48 hours post injection
measure: Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors
timeFrame: 24- and 48 hours post injection
measure: Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake
timeFrame: 24- and 48 hours post injection
measure: Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors
timeFrame: 24- and 48 hours post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lance Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall LT, Titz B, Robins HI, Bednarz BP, Perlman SB, Weichert JP, Kuo JS. PET/CT imaging of the diapeutic alkylphosphocholine analog 124I-CLR1404 in high and low-grade brain tumors. Am J Nucl Med Mol Imaging. 2017 Sep 1;7(4):157-166. eCollection 2017.