Evaluation of PET/MRI in Children With Cancer
1 other identifier
interventional
8
1 country
1
Brief Summary
This research study is a Pilot study (a small preliminary study to assess the feasibility of a larger, more in depth study involving a new test or procedure) and is being done to evaluate the feasibility and accuracy of PET/MRI in the evaluation of cancer. PET/MRI is a FDA approved technology that is currently being studied to assess its accuracy and utility in the diagnosis and management of a variety of diseases and patient populations. The focus of this particular study will be to compare the performance of PET/MRI in its ability to detect and characterize cancerous tumors using positron emission topography and computed tomography (PET/CT) as a reference standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2012
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedFebruary 17, 2025
February 1, 2025
12.2 years
April 22, 2013
February 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Imaging Quality between PET-MRI and PET-CT
To perform a qualitative comparison of image quality between PET-MRI and PET-CT exams being performed on pediatric oncology patients during the same visit
2 years
Secondary Outcomes (2)
Comparison of PET-MRI SUV Values and PET-CT FDG Reference
2 years
Assessment of Unexpected Indeterminate Lesions
2 years
Study Arms (1)
Imaging
EXPERIMENTALPET-MRI PET-CT
Interventions
Eligibility Criteria
You may qualify if:
- Able to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history
You may not qualify if:
- Requirement for sedation or anesthesia of any kind in order to undergo MRI scanning
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
- Pregnancy or breastfeeding
- Pre-existing medical conditions or claustrophobic reactions, and any greater than normal potential for cardiac arrest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Gee, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 25, 2013
Study Start
October 31, 2012
Primary Completion
January 1, 2025
Study Completion
January 15, 2025
Last Updated
February 17, 2025
Record last verified: 2025-02