Pediatric PET/MR Image Registry

Recruiting

• Conditions: Lymphoma; Osteosarcoma; Soft Tissue
• Interventions: Diagnostic Test: PET/MR imaging; Diagnostic Test: MR imaging; Diagnostic Test: PET/CT imaging

• Registration Number: NCT03458520
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Image Registry	PET/CT imaging	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)
Image Registry	PET/MR imaging	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)
Image Registry	MR imaging	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)

Primary Outcome Measures

Name	Time	Method
Number of tumors	up to 12 months	Number of tumors detected on whole body MRI, PET/MR and (if available) PET/CT scans.

Secondary Outcome Measures

Name	Time	Method
Metabolic activity of tumors	up to 12 months	Metabolic activity of tumors determined by Standardized Uptake Values (SUV) on PET/MR and (if available) PET/CT scans.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States