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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-0830 | Other Identifier | Institutional Review Board | |
| NCI-2012-02080 | Registry Identifier | NCI Trial ID | |
| A539300 | Other Identifier | UW Madison | |
| SMPH\RADIOLOGY\RADIOLOGY | Other Identifier | UW Madison |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I124-NM404 brain metastases or GBM imaging | Experimental | injection of I-124NM404 for imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NM404 | Drug | injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging Other Names: PET imaging with I-124 NM404 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Hall, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28913154 | Result | 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. |
| Label | URL |
|---|---|
| Impact of PET and MRI threshold-based tumor volume segmentation on patient-specific | View source |
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Participants were enrolled from March 2012 to September 2014 at the University of Wisconsin Hospital and Clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | I124-NM404 Brain Metastases or GBM Imaging | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I124-NM404 Brain Metastases or GBM Imaging | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of 12 subjects, only 8 had evaluable data. | Posted | Mean | Standard Deviation | Ratio of PET SUV | 24- and 48 hours post injection |
|
Adverse event data were collected for up to 48 hours (until the time of the final scan).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I124-NM404 Brain Metastases or GBM Imaging | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lance Hall | University of Wisconsin Carbone Cancer Center | 608-263-5585 | lhall@uwhealth.org |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| NM404 | Drug | injection of an experimental imaging agent, 5mCi I-124NM404 |
|
| PET/CT imaging of the diapeutic alkylphosphocholine analog 124I-CLR1404 in high and low-grade brain tumors | View source |
| University of Wisconsin Carbone Cancer Center | View source |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| 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. | Of 12 participants, 8 had evaluable TBR data. | Posted | Mean | Standard Deviation | Ratio of PET SUV | 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. | Of 12 participants, 8 had evaluable TBR data. | Posted | Mean | Standard Deviation | Ratio of PET SUV | 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. | Of 12 participants, 8 had evaluable tumor to blood pool ratio data. | Posted | Mean | Standard Deviation | Ratio of PET SUV | 24- and 48 hours post injection |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |