A Phase 1/2 interventional study of WB-DW-MR scan and 18-F-FDG PET scan in Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 6 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Stanford University · Phase 1/2, Interventional, and Diagnostic
A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.
Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans (new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 158 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
simultaneous WB-DW-MR scan and 18-F FDG PET scan
Procedure: WB-DW-MR scan · Procedure: 18-F-FDG PET scan · Drug: Ferumoxytol · Procedure: 18-F-FDG PET/MR scan
WB-DW-MR scans will be obtained on a 3T PET-MR system
Also known as: Whole Body Diffusion Weighted MR scan
Also known as: Fludeoxyglucose PET scan
Also known as: feraheme
Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV)
Clinical response prediction according to maximum Standard Uptake Value (SUV), assessed using receiver operating characteristic (ROC) curve analysis. Higher AUC values indicate better discrimination between responders and non-responders.
Time frame: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
Area Under the Receiver Operating Characteristic Curve (ROC) of Minimum Apparent Diffusion Coefficient (ADC)
Clinical response prediction according to minimum Apparent Diffusion Coefficient (ADC) values, assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) measures the ability of minimum ADC values to distinguish responders from non-responders, with higher AUC values indicating better predictive performance.
Time frame: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
Sensitivity and Specificity of WB-DW-MR Compared to 18F-FDG PET/CT
Comparison of the sensitivity (true positive rate) and specificity (true negative rate) of WB-DW-MR scans versus standard 18F-FDG PET/CT scans for tumor detection and clinical response assessment, using imaging findings compared with the clinical reference standard (biopsy and/or follow-up imaging).
Time frame: 3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
Signal-to-Noise Ratio as a Measure of Technical Optimization of Whole-Body Diffusion-Weighted MRI (WB-DW-MRI)
Signal-to-noise ratio (SNR) was assessed to evaluate and optimize pulse sequence parameters and b-values for whole-body diffusion-weighted MRI. SNR was calculated from signal intensity measurements obtained from bone marrow metastases and normal bone marrow regions on diffusion-weighted MRI images. b50 images provide higher signal-to-noise ratio and visualization of tissue perfusion/anatomy, while b800 images emphasize restricted diffusion associated with malignancy and suppress background tissue signal.
Time frame: Baseline (day of scan)
| Milestone | WB-DW-MR Scan |
|---|---|
| Started | 158 |
| Completed | 157 |
| Not completed | 1 |
Clinical response prediction according to maximum Standard Uptake Value (SUV), assessed using receiver operating characteristic (ROC) curve analysis. Higher AUC values indicate better discrimination between responders and non-responders.
| percentage | Standard 18F-FDG PET/CT |
|---|---|
| Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV) | 100 (99 to 100) |
Signal-to-noise ratio (SNR) was assessed to evaluate and optimize pulse sequence parameters and b-values for whole-body diffusion-weighted MRI. SNR was calculated from signal intensity measurements obtained from bone marrow metastases and normal bone marrow regions on diffusion-weighted MRI images. b50 images provide higher signal-to-noise ratio and visualization of tissue perfusion/anatomy, while b800 images emphasize restricted diffusion associated with malignancy and suppress background tissue signal.
| signal-to-noise ratio | WB-DW-MR Scan - b50 | WB-DW-MR Scan - b800 |
|---|---|---|
| bone marrow metastases | 978.436 ± 1239.436 | 499.638 ± 612.721 |
| normal bone marrow | 108.881 ± 109.813 | 86.280 ± 89.120 |
Clinical response prediction according to minimum Apparent Diffusion Coefficient (ADC) values, assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) measures the ability of minimum ADC values to distinguish responders from non-responders, with higher AUC values indicating better predictive performance.
| percentage | WB-DW-MR Scan |
|---|---|
| Area Under the Receiver Operating Characteristic Curve (ROC) of Minimum Apparent Diffusion Coefficient (ADC) | 98 (94 to 100) |
Comparison of the sensitivity (true positive rate) and specificity (true negative rate) of WB-DW-MR scans versus standard 18F-FDG PET/CT scans for tumor detection and clinical response assessment, using imaging findings compared with the clinical reference standard (biopsy and/or follow-up imaging).
| percentage | WB-DW-MR Scan | Standard 18F-FDG PET/CT |
|---|---|---|
| Sensitivity (true positive rate) | 96 (86 to 99) | 100 (93 to 100) |
| Specificity (true negative rate) | 100 (54 to 100) | 100 (54 to 100) |
Collected over Baseline (day of scan) through 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WB-DW-MR Scan | 6/158 (3.8%) | 0/158 (0%) | 1/158 (0.6%) |
| Event | WB-DW-MR Scan |
|---|---|
| Allergic ReactionImmune system disorders | 1/158 |
| Age, Customized(Participants) | WB-DW-MR Scan |
|---|---|
| Pediatric (<18 years) | 93 |
| Young adults (≥18 years) | 65 |
| Sex: Female, Male(Participants) | WB-DW-MR Scan |
|---|---|
| Female | 63 |
| Male | 95 |
| Ethnicity (NIH/OMB)(Participants) | WB-DW-MR Scan |
|---|---|
| Hispanic or Latino | 52 |
| Not Hispanic or Latino | 106 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | WB-DW-MR Scan |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 28 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 2 |
| White | 113 |
| More than one race | 6 |
| Unknown or Not Reported | 7 |
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