PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer

NCT ID: NCT02287636

Last Updated: 2020-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot clinical trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. It is not yet known whether PET/MRI works better than PET/CT in diagnosing younger patients with cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.

SECONDARY OBJECTIVES:

I. Obtain quantitative measurements in various body regions of standardized uptake values (SUV) in normal tissue and foci of pathologic tracer uptake in PET/MRI of pediatric patients with oncologic disease using various magnetic resonance attenuation correction (MRAC) methods and compare those to respective SUV based on CT attenuation correction.

II. Assess the potential for radiation dose reduction with PET/MRI when eliminating CT radiation dose.

III. Assess time efforts and workflow improvement with PET/MRI compared to sequential PET/CT plus MRI.

OUTLINE:

Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)

Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.

Group Type EXPERIMENTAL

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo fludeoxyglucose F 18 PET/CT

positron emission tomography

Intervention Type PROCEDURE

Undergo fludeoxyglucose F 18 PET/CT

computed tomography

Intervention Type PROCEDURE

Undergo fludeoxyglucose F 18 PET/CT

positron emission tomography

Intervention Type PROCEDURE

Undergo PET/MRI

magnetic resonance imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fludeoxyglucose F 18

Undergo fludeoxyglucose F 18 PET/CT

Intervention Type RADIATION

positron emission tomography

Undergo fludeoxyglucose F 18 PET/CT

Intervention Type PROCEDURE

computed tomography

Undergo fludeoxyglucose F 18 PET/CT

Intervention Type PROCEDURE

positron emission tomography

Undergo PET/MRI

Intervention Type PROCEDURE

magnetic resonance imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18FDG FDG FDG-PET PET PET scan tomography, emission computed tomography, computed FDG-PET PET PET scan tomography, emission computed MRI NMR imaging NMRI nuclear magnetic resonance imaging

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who are referred by their physician for clinically indicated diagnostic fludeoxyglucose F 18 (18F-FDG) PET/CT (with or without clinically indicated diagnostic MRI)
* Subjects with malignancies including hematologic disorders
* Subjects NOT requiring sedation or anesthesia
* Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging)

Exclusion Criteria

* Subjects who are unable or unwilling to give their assent to both examinations if \> 7 years old
* Subjects requiring general anesthesia or sedation in order to undergo PET/CT or MRI
* Subjects unable to undergo magnetic resonance (MR) scanning due to exclusion by University Hospitals-Case Medical Center restriction policies for Magnetic Resonance Imaging (UHCMC MRI restriction policies) as mentioned in the standard UHCMC MRI informed consent form
* Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
* Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Bangert

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2014-00828

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE1Z13

Identifier Type: -

Identifier Source: secondary_id

CASE 1Z13

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE1Z13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET/MRI in Endometrial Cancer
NCT05390021 WITHDRAWN NA