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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

Lance Hall, MD

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

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

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.

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.

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.

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.

University of Wisconsin, Madison

Subjects are monitored for adverse events (AEs) by the research team and reported by the principle investigator or co-investigators. Subjects are observed during the injection of 124I-NM404 and for 30 minutes after injection. Subjects are also monitored at each PET/CT scanning session. Approximately 2 - 4 weeks after injection of 124I-NM404, subjects were contacted by phone or other means and/or medical records were reviewed, if available, to assess for any AEs. AE data collection is complete.

Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.

Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days.

I124-NM404 Brain Metastases or GBM Imaging

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Lance Hall

24 hours

48 hours

Of 12 subjects, only 8 had evaluable data.

Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake

Of 12 participants, 8 had evaluable TBR data.

Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors

Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake

Of 12 participants, 8 had evaluable tumor to blood pool ratio data.

Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors

Overall Study

determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404

injection of either 2.0mCi or 5.0mCi I-124 NM404

Scott Perlman, MD, MS

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.

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404	NCT01540513	Glioblastoma Mu... Brain Metastase...	NM404 NM404	18 Years -	University of Wisconsin, Madison
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404	NCT01540513	Glioblastoma Mu... Brain Metastase...	NM404 NM404	18 Years -	University of Wisconsin, Madison
PET/CT Imaging of Malignant Brain Tumors With 124I-NM404	NCT01516905	Glioblastoma Brain Metastase...	NM404	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for nm404

Every month we try and update this database with for nm404 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nm404

Every month we try and update this database with for nm404 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nm404 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.