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Evaluation of PET/MRI in Children With Cancer

Primary Purpose

Hematologic Malignancy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-MRI
PET-CT
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hematologic Malignancy focused on measuring Pediatric

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging

Arm Description

PET-MRI PET-CT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of PET-MRI SUV Values and PET-CT FDG Reference
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
Assessment of Unexpected Indeterminate Lesions
To assess the number of unexpected indeterminate lesions detected on PET-MRI and PET-CT studies requiring additional workup

Full Information

First Posted
April 22, 2013
Last Updated
August 30, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01839747
Brief Title
Evaluation of PET/MRI in Children With Cancer
Official Title
Evaluation of PET/MRI in Children With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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: You will schedule your PET/CT examination with the MGH radiology department according to the orders and instructions of your oncologist (cancer doctor) Study personnel will coordinate the scheduling of your PET/MRI examination to coincide with date and time of your PET/CT examination 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 The PET/MRI will take up to 60 minutes to complete and after it is completed you will be free to go 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. 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 The study will last for 12 months, after which time you will no longer be enrolled

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Pediatric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging
Arm Type
Experimental
Arm Description
PET-MRI PET-CT
Intervention Type
Procedure
Intervention Name(s)
PET-MRI
Intervention Description
Imaging
Intervention Type
Procedure
Intervention Name(s)
PET-CT
Intervention Description
Imaging
Primary Outcome Measure Information:
Title
Comparison of Imaging Quality between PET-MRI and PET-CT
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comparison of PET-MRI SUV Values and PET-CT FDG Reference
Description
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
Time Frame
2 years
Title
Assessment of Unexpected Indeterminate Lesions
Description
To assess the number of unexpected indeterminate lesions detected on PET-MRI and PET-CT studies requiring additional workup
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Gee, MD, PhD
Phone
6177244207
Email
msgee@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gee, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gee, MD, PhD
Phone
617-724-4207
Email
msgee@partners.org
First Name & Middle Initial & Last Name & Degree
Michael Gee, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of PET/MRI in Children With Cancer

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