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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-20221 | Other Identifier | Stanford IRB | |
| PEDSVAR0017 | Other Identifier | OnCore |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WB-DW-MR scan | Experimental | simultaneous WB-DW-MR scan and 18-F FDG PET scan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WB-DW-MR scan | Procedure | WB-DW-MR scans will be obtained on a 3T PET-MR system |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of sensitivity, specificity and accuracy of WB-DW-MR scans to 18-F FDG PET scans. | To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy and follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas. | The outcome will be measured after image acquisition |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of sensitivity, specificity and accuracy of Ferumoxytol-enhanced whole-body 18-F FDG PET/MR-scans versus standard clinical Gadolinium-enhanced whole-body 18-F FDG PET/MR-scans. | To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy or follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Barrato | Contact | 415 307 1990 | lbaratto@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heike Daldrup-Link | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Cancer Institute | Recruiting | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36999999 | Derived | Rashidi A, Baratto L, Theruvath AJ, Greene EB, Jayapal P, Hawk KE, Lu R, Seekins J, Spunt SL, Pribnow A, Daldrup-Link HE. Improved Detection of Bone Metastases in Children and Young Adults with Ferumoxytol-enhanced MRI. Radiol Imaging Cancer. 2023 Mar;5(2):e220080. doi: 10.1148/rycan.220080. | |
| 34870211 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 10, 2026 | |
| Reset | Apr 30, 2026 | |
| Release | May 15, 2026 | |
| Reset | Jun 11, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 10, 2026 | Apr 30, 2026 | |||
| May 15, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| 18-F-FDG PET scan | Procedure |
|
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| Ferumoxytol | Drug |
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| 18-F-FDG PET/MR scan | Procedure |
|
| 2 years |
| Theruvath AJ, Siedek F, Yerneni K, Muehe AM, Spunt SL, Pribnow A, Moseley M, Lu Y, Zhao Q, Gulaka P, Chaudhari A, Daldrup-Link HE. Validation of Deep Learning-based Augmentation for Reduced 18F-FDG Dose for PET/MRI in Children and Young Adults with Lymphoma. Radiol Artif Intell. 2021 Oct 6;3(6):e200232. doi: 10.1148/ryai.2021200232. eCollection 2021 Nov. |
| 32368961 | Derived | Theruvath AJ, Siedek F, Muehe AM, Garcia-Diaz J, Kirchner J, Martin O, Link MP, Spunt S, Pribnow A, Rosenberg J, Herrmann K, Gatidis S, Schafer JF, Moseley M, Umutlu L, Daldrup-Link HE. Therapy Response Assessment of Pediatric Tumors with Whole-Body Diffusion-weighted MRI and FDG PET/MRI. Radiology. 2020 Jul;296(1):143-151. doi: 10.1148/radiol.2020192508. Epub 2020 May 5. |
| 24559803 | Derived | Klenk C, Gawande R, Uslu L, Khurana A, Qiu D, Quon A, Donig J, Rosenberg J, Luna-Fineman S, Moseley M, Daldrup-Link HE. Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. Lancet Oncol. 2014 Mar;15(3):275-85. doi: 10.1016/S1470-2045(14)70021-X. Epub 2014 Feb 19. |
| Jun 11, 2026 |
| Jun 26, 2026 |
| D008903 |
| Minerals |