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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516905
• Other study ID #: RO11310
• Secondary ID: 1R01CA158800-01N
• Status: Completed
• Start date: December 2011
• Est. completion date: May 17, 2016

Study information

• Verified date: February 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 17, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Glioblastoma

Intervention

Drug:
• NM404
injection of either 2.0mCi or 5.0mCi I-124 NM404

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Wisconsin Carbone Cancer Center