Evaluation of PET/MRI in Children With Cancer

August 30, 2021 updated by: Michael Gee, Massachusetts General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

If you agree to participate in this study you will be asked to fill out a screening questionnaire to determine if you can participate. No additional screening tests or procedures will be necessary prior to your participation in this study.

If the screening questionnaire shows that you are eligible to participate in the research study, you will be scheduled to undergo your PET/MRI in conjunction with your PET/CT. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

After th screening procedures confirm that you are eligible to participate in the research study:

  1. You will schedule your PET/CT examination with the MGH radiology department according to the orders and instructions of your oncologist (cancer doctor)
  2. Study personnel will coordinate the scheduling of your PET/MRI examination to coincide with date and time of your PET/CT examination
  3. Following the performance of your PET/CT examination you will be transported (with your accompanying family member(s)) to the Charlestown Navy Yard MGH imaging facility where you will undergo your PET/MRI examination. No additional dose of radioactive tracer (a substance which is labeled with a radioactive molecule that can be tracked within your body based on the radiation it emits) will be given as part of your PET/MRI examination
  4. The PET/MRI will take up to 60 minutes to complete and after it is completed you will be free to go
  5. The PET/MRI images will be interpreted by physicians (trained radiologists) as part of the study analysis; however no report of the findings will be made available to you. You will have access to the results of the PET/CT examination as you would any other clinical imaging examination.
  6. If you are willing, with each subsequent PET/CT examination you undergo while enrolled in the study, you will also undergo a PET/MRI examination
  7. The study will last for 12 months, after which time you will no longer be enrolled

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Michael Gee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging
PET-MRI PET-CT
Procedure: PET-MRI
Imaging
Procedure: PET-CT
Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Imaging Quality between PET-MRI and PET-CT
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of PET-MRI SUV Values and PET-CT FDG Reference
Time Frame: 2 years
To compare the ability of PET-MRI to determine the extent of active malignancy by comparing PET-MRI SUV values with PET-CT FDG reference
2 years
Assessment of Unexpected Indeterminate Lesions
Time Frame: 2 years
To assess the number of unexpected indeterminate lesions detected on PET-MRI and PET-CT studies requiring additional workup
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Michael Gee, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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