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Pediatric PET/MR Image Registry

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ClinicalTrials.gov Identifier: NCT03458520
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The purpose of this study is to compare whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and (if available) PET/Computed Tomography (CT) imaging for the diagnosis of tumors in children and young adults. Sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.

Condition or disease Intervention/treatment
Soft Tissue Lymphoma Osteosarcoma Diagnostic Test: PET/MR imaging Diagnostic Test: MR imaging Diagnostic Test: PET/CT imaging

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric PET/MR Image Registry
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025


Group/Cohort Intervention/treatment
Image Registry
patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor will receive MR imaging, PET/MR imaging (and if available, PET/CT imaging)
Diagnostic Test: PET/MR imaging
undergo PET/MR imaging
Other Name: positron emission tomography

Diagnostic Test: MR imaging
Undergo MR imaging
Other Name: magnetic resonance imaging

Diagnostic Test: PET/CT imaging
Undergo PET/CT imaging
Other Name: computed tomography




Primary Outcome Measures :
  1. Number of tumors [ Time Frame: up to 12 months ]
    Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.


Secondary Outcome Measures :
  1. Metabolic activity of tumors [ Time Frame: up to 12 months ]
    Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric and young adult (<40 years) male or female subjects with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor
Criteria

Inclusion Criteria:

  • Patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor.
  • We might also include some patients with leukemia if there is concern for a focal lesion in any of their organs.
  • Participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry.

Exclusion Criteria:

  • Patient has contraindications for MRI or PET/MR. This includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level > 200 mg/dl.
  • Lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age).
  • Patient has a CNS primary tumor.
  • Pregnant women and fetuses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458520


Contacts
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Contact: Anne Muehe 650-720-8601 amuehe@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Anne Muehe    650-720-8601    amuehe@stanford.edu   
Principal Investigator: Heike Daldrup-Link, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Heike Daldrup-Link, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03458520    
Other Study ID Numbers: IRB-44706
PEDSVAR0049 ( Other Identifier: OnCore )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma