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Evaluation of PET/MRI in Children With Cancer


N/A
3 Years
18 Years
Open (Enrolling)
Both
Hematologic Malignancy

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Trial Information

Evaluation of PET/MRI in Children With Cancer


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Comparison of Imaging Quality between PET-MRI and PET-CT

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael Gee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

12-307

NCT ID:

NCT01839747

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Hematologic Malignancy
  • Pediatric
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617