Pediatric PET/MR Image Registry

Lymphoma Clinical Trial

Official title:

Pediatric PET/MR Image Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458520
• Other study ID #: IRB-44706
• Secondary ID: PEDSVAR0049
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Lymphoma
• Osteosarcoma
• Soft Tissue

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