CancerPhase 1/2NCT01542879
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
A Phase 1/2 study testing WB-DW-MR scan, 18-F-FDG PET scan and Ferumoxytol in people with Cancer, run by Stanford University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Cancer
- What is being tested?
- WB-DW-MR scan, 18-F-FDG PET scan and Ferumoxytol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2012to 8 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
- Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
- There will be no restrictions on prior treatment.
- Very young children who need sedation or anesthesia will be excluded from the study.
- In this pediatric \& adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.
Who cannot join
- MR-incompatible metal implants,
- need of sedation or claustrophobia.
- Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
- There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
- History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
- Pregnant women and fetuses.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Institute
Stanford, California, 94305
About this study
Official title: Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- WB-DW-MR scan, 18-F-FDG PET scan, Ferumoxytol, 18-F-FDG PET/MR scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-DW-MR scanProcedure or surgery
Also called Whole Body Diffusion Weighted MR scan
WB-DW-MR scans will be obtained on a 3T PET-MR system
18-F-FDG PET scanProcedure or surgery
Also called Fludeoxyglucose PET scan
FerumoxytolDrug
Also called feraheme
18-F-FDG PET/MR scanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| WB-DW-MR scan | Experimental | simultaneous WB-DW-MR scan and 18-F FDG PET scan Receives: Procedure: WB-DW-MR scan; Procedure: 18-F-FDG PET scan; Drug: Ferumoxytol; Procedure: 18-F-FDG PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
Secondary outcomes (1)
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.
Measured: Baseline (day of scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start22 Feb 2012
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Heike Daldrup-Link, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542879
- Sponsor's protocol ID
- IRB-20221
- Other IDs
- NCI-2012-015321, 1R01CA269231-01A1
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2012
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36999999Theruvath 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.
PubMed 34870211Theruvath 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.
PubMed 32368961Klenk 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.
PubMed 24559803
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.
- ClinicalTrials.gov ID
- NCT01542879
- Acronym / sponsor ID
- IRB-20221
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Thrasher Research Fund
- Study start
- 22 Feb 2012 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WB-DW-MR scan | Experimental | Procedure: WB-DW-MR scan, Procedure: 18-F-FDG PET scan, Drug: Ferumoxytol, Procedure: 18-F-FDG PET/MR scansimultaneous WB-DW-MR scan and 18-F FDG PET scan |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and
- Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure.
- There will be no restrictions on prior treatment.
- Very young children who need sedation or anesthesia will be excluded from the study.
- In this pediatric \& adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.
Key exclusion criteria (6 listed)
- MR-incompatible metal implants,
- need of sedation or claustrophobia.
- Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol)
- There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol
- History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB-DW-MR scanAlso: Whole Body Diffusion Weighted MR scanWB-DW-MR scans will be obtained on a 3T PET-MR system | Procedure or surgery | WB-DW-MR scan |
| 18-F-FDG PET scanAlso: Fludeoxyglucose PET scan | Procedure or surgery | WB-DW-MR scan |
| FerumoxytolAlso: feraheme | Drug | WB-DW-MR scan |
| 18-F-FDG PET/MR scan | Procedure or surgery | WB-DW-MR scan |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV)
Time frame: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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.
Area Under the Receiver Operating Characteristic Curve (ROC) of Minimum Apparent Diffusion Coefficient (ADC)
Time frame: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)
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.
Sensitivity and Specificity of WB-DW-MR Compared to 18F-FDG PET/CT
Time frame: 3 to 14 weeks post-treatment (interval determined by tumor type and treatment protocol)
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).
1 secondary outcome
Signal-to-Noise Ratio as a Measure of Technical Optimization of Whole-Body Diffusion-Weighted MRI (WB-DW-MRI)
Time frame: Baseline (day of scan)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36999999Rashidi 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.
- Derived from this study: PubMed 34870211Theruvath 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.
- Derived from this study: PubMed 32368961Theruvath 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.
- Derived from this study: PubMed 24559803Klenk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike Daldrup-Link principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WB-DW-MR scan, 18-F-FDG PET scan and Ferumoxytol in people with Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (ROC) of Maximum Standard Uptake Value (SUV) (time frame: Baseline (day of scan), and 3 to 14 weeks post treatment (interval determined by tumor type and treatment protocol)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542879, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.