- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458520
- Original Trial
Pediatric PET/MR Image Registry
February 5, 2026 updated by: Stanford University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anne Muehe
- Phone Number: 650-720-8601
- Email: amuehe@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Stanford University, School of Medicine
-
Principal Investigator:
- Heike Daldrup-Link, MD
-
Contact:
- Anne Muehe
- Phone Number: 650-720-8601
- Email: amuehe@stanford.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 40 years (Child, Adult)
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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)
|
undergo PET/MR imaging
Other Names:
Undergo MR imaging
Other Names:
Undergo PET/CT imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heike Daldrup-Link, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 2, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 8, 2018
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Sarcoma
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Hemic and Lymphatic Diseases
- Lymphoma
- Osteosarcoma
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Radiography
- Image Interpretation, Computer-Assisted
- Radiographic Image Enhancement
- Image Enhancement
- Photography
- Tomography, X-Ray
- Tomography, Emission-Computed
- Radionuclide Imaging
- Diagnostic Techniques, Radioisotope
- Magnetic Resonance Imaging
- Tomography, X-Ray Computed
- Positron-Emission Tomography
Other Study ID Numbers
- IRB-44706
- PEDSVAR0049 (Other Identifier: OnCore)
- 5U24CA264298-04 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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