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

NCT ID: NCT01540513

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-10-31

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

Conditions

Glioblastoma Multiforme; Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

I124-NM404 brain metastases or GBM imaging

injection of I-124NM404 for imaging

Group Type: EXPERIMENTAL

NM404

Intervention Type: DRUG

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

Other Names:

PET imaging with I-124 NM404

NM404

Intervention Type: DRUG

injection of an experimental imaging agent, 5mCi I-124NM404

Interventions

NM404

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

Other Names:

PET imaging with I-124 NM404

Intervention Type: DRUG

NM404

injection of an experimental imaging agent, 5mCi I-124NM404

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lance Hall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 28913154 (View on PubMed)

Related Links

http://iopscience.iop.org/article/10.1088/1361-6560/aa716d/meta

Impact of PET and MRI threshold-based tumor volume segmentation on patient-specific

http://www.ajnmmi.us/files/ajnmmi0058850.pdf

PET/CT imaging of the diapeutic alkylphosphocholine analog 124I-CLR1404 in high and low-grade brain tumors

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

2011-0830

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-02080

Identifier Type: REGISTRY

Identifier Source: secondary_id

A539300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\RADIOLOGY\RADIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

RO11360

Identifier Type: -

Identifier Source: org_study_id