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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540513
• Other study ID #: RO11360
• Secondary ID: 2011-0830NCI-201
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• NM404
injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404
• NM404
injection of an experimental imaging agent, 5mCi I-124NM404

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hall LT, Titz B, Robins HI, Bednarz BP, Perlman SB, Weichert JP, Kuo JS. PET/CT imaging of the diapeutic alkylphosphocholine analog (124)I-CLR1404 in high and low-grade brain tumors. Am J Nucl Med Mol Imaging. 2017 Sep 1;7(4):157-166. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake	TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection.	24- and 48 hours post injection
Primary	Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors	TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection.	24- and 48 hours post injection
Primary	Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake	Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection.	24- and 48 hours post injection
Primary	Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors	Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection.	24- and 48 hours post injection

External Links

•   Alkylphospohocholine Analogs for Broad-Spectrum Cancer Imaging and Therapy
•   Impact of PET and MRI threshold-based tumor volume segmentation on patient-specific
•   PET/CT imaging of the diapeutic alkylphosphocholine analog 124I-CLR1404 in high and low-grade brain tumors
•   University of Wisconsin Carbone Cancer Center