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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03458520
Other study ID # IRB-44706
Secondary ID PEDSVAR0049
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date March 1, 2025

Study information

Verified date November 2023
Source Stanford University
Contact Anne Muehe
Phone 650-720-8601
Email amuehe@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
PET/MR imaging
undergo PET/MR imaging
MR imaging
Undergo MR imaging
PET/CT imaging
Undergo PET/CT imaging

Locations

Country Name City State
United States Stanford University, School of Medicine Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of tumors Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans. up to 12 months
Secondary Metabolic activity of tumors Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans. up to 12 months
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