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

University of Wisconsin (UW)

Status

Completed

Conditions

Brain Metastases

Glioblastoma Multiforme

Treatments

Drug: NM404

Study type

Interventional

Funder types

Other

Identifiers

NCT01540513

2011-0830 (Other Identifier)

NCI-2012-02080 (Registry Identifier)

RO11360

A539300 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.