NCT02287636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration 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

April 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

April 17, 2014

Results QC Date

February 7, 2020

Last Update Submit

February 21, 2020

Conditions

Childhood Cancer

Outcome Measures

Primary Outcomes (2)

  • Diagnostic Accuracy of PET/MRI

    Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.

    1 day

  • Diagnostic Accuracy of PET/CT

    Evaluation of the PET/CT imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/CT with PET/MRI.

    1 day

Secondary Outcomes (4)

  • SUVs Using PET/MRI

    1 day

  • SUVs Using PET/CT

    1 day

  • Radiation Dose Reduction Associated With PET/MRI

    1 day

  • Time Effort Associated With the PET/MRI

    1 day

Study Arms (1)

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

EXPERIMENTAL

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

Radiation: fludeoxyglucose F 18Procedure: positron emission tomographyProcedure: computed tomographyProcedure: magnetic resonance imaging

Interventions

fludeoxyglucose F 18RADIATION

Undergo fludeoxyglucose F 18 PET/CT

Also known as: 18FDG, FDG
Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)
positron emission tomographyPROCEDURE

Undergo fludeoxyglucose F 18 PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)
computed tomographyPROCEDURE

Undergo fludeoxyglucose F 18 PET/CT

Also known as: tomography, computed
Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)
magnetic resonance imagingPROCEDURE

Undergo PET/MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.

Results Point of Contact

Title
Philipp Frank Graner
Organization
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
philipp.graner@uhhospitals.org
+1 216-844-8275

Study Officials

  • Barbara Bangert

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

November 11, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 24, 2020

Results First Posted

February 24, 2020

Record last verified: 2020-02

Locations

US(1)