NCT01839747

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

12.2 years

First QC Date

April 22, 2013

Last Update Submit

February 13, 2025

Conditions

Keywords

Pediatric

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

EXPERIMENTAL

PET-MRI PET-CT

Procedure: PET-MRIProcedure: PET-CT

Interventions

PET-MRIPROCEDURE

Imaging

Imaging
PET-CTPROCEDURE

Imaging

Imaging

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Michael Gee, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

Locations