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Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Primary endpoint(s) modified Show 12 more changesShow less
    • Results posted: Oct 6, 2026
    • Lead sponsor: Heike E Daldrup-Link to Stanford University
    • Trial completed
    • Final enrollment: 158 participants (planned 75)
    • Primary completion date changed from estimate of Oct 2025 to Aug 8, 2022
    • Start date: Feb 2012 to Feb 22, 2012
    • Interventions: 18-F-FDG PET scan (Procedure), 18-F-FDG PET/MR scan (Procedure), Ferumoxytol (Drug), WB-DW-MR scan (Procedure) to 18-F-FDG PET scan (Procedure), 18-F-FDG PET/MR scan (Procedure), Ferumoxytol (Drug), WB-DW-MR scan (Procedure)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoint revised
    • Site details revised
    • Collaborators expanded, about 7 words
    • Publications: details revised at 4 of 4 entries
  2. Secondary endpoints: details revised at 1 of 1 entryv19
  3. Primary completion date: Oct 2022 to Oct 2025
    • Study completion date: Dec 2022 to Dec 2026
    v18
  4. Primary completion date: Jan 2022 to Oct 2022
    • Study completion date: Jan 2022 to Dec 2022
    v17
  5. Primary completion date: Dec 2020 to Jan 2022
    • Study completion date: Mar 2021 to Jan 2022
    • Site contact updated
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Jun 2020 to Dec 2020
    • Study completion date: Jul 2020 to Mar 2021
    v15
  2. Primary completion date: Jun 2019 to Jun 2020
    • Study completion date: Jul 2019 to Jul 2020
    v14
  3. Phase: Not applicable to Phase 1/2v13 Show 7 more changesShow less
    • Enrollment target: 100 to 75
    • Interventions: 18F-FDG PET scan (Procedure), Ferumoxytol (Drug), WB-DW-MR scan (Procedure) to 18-F-FDG PET scan (Procedure), 18-F-FDG PET/MR scan (Procedure), Ferumoxytol (Drug), WB-DW-MR scan (Procedure)
    • Eligibility criteria expanded, about 117 words
    • Secondary endpoints expanded, about 20 words
    • Primary endpoint revised
    • Study description shortened, about 225 words
    • Study title shortened, about 1 word
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date: Oct 2017 to Jun 2019
    • Study completion date: Nov 2017 to Jul 2019
    v11
  6. Enrollment target: 50 to 100
    • Interventions: WB-DW-MR scan (Device) to 18F-FDG PET scan (Procedure), Ferumoxytol (Drug), WB-DW-MR scan (Procedure)
    v10
  7. Primary completion date: Oct 2016 to Oct 2017
    • Study completion date: Nov 2016 to Nov 2017
    • Study description expanded, about 39 words
    v9
  8. Primary completion date: Jul 2015 to Oct 2016
    • Study completion date: Jul 2015 to Nov 2016
    • Site contact updated
    v8
  9. Site contact updatedv7
  10. Lead sponsor: Stanford University to Heike E Daldrup-Link
    • Primary and study completion dates: Mar 2014 to Jul 2015
    • Study description expanded, about 213 words
    v6
  11. Eligibility criteria revisedv5
  12. Re-verified, no change to tracked fieldsv4
  13. Primary and study completion dates: Mar 2013 to Mar 2014
    • Eligibility criteria revised
    • Site contact updated
    v3
  14. Phase: Not specified to Not applicablev2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01542879
Lead Sponsor Stanford University
Collaborators: National Cancer Institute (NCI), Thrasher Research Fund
Conditions
(from sponsor)		 Cancer
Related terms Neoplasms
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov