An interventional study of NM404 and NM404 in Glioblastoma Multiforme and Brain Metastases, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Diagnostic
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
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
injection of I-124NM404 for imaging
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
injection of an experimental imaging agent, 5mCi I-124NM404
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.
Time frame: 24- and 48 hours post injection
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.
Time frame: 24- and 48 hours post injection
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.
Time frame: 24- and 48 hours post injection
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.
Time frame: 24- and 48 hours post injection
Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.
| Milestone | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Ratio of PET SUV | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| 24 hours | 8.25 ± 4.16 |
| 48 hours | 8.75 ± 3.60 |
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.
| Ratio of PET SUV | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| 24 hours | 9.32 ± 4.33 |
| 48 hours | 10.04 ± 3.15 |
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.
| Ratio of PET SUV | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| 24 hours | 2.86 ± 1.77 |
| 48 hours | 2.93 ± 2.07 |
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.
| Ratio of PET SUV | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| 24 hours | 3.35 ± 1.75 |
| 48 hours | 3.45 ± 2.15 |
Collected over Adverse event data were collected for up to 48 hours (until the time of the final scan).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| I124-NM404 Brain Metastases or GBM Imaging | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 1 |
| Age, Continuous(years) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| Mean | 43.9 (23 to 66) |
| Sex: Female, Male(Participants) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| Female | 4 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | I124-NM404 Brain Metastases or GBM Imaging |
|---|---|
| United States | 12 |
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University of Wisconsin, Madison