Childhood CancerNCT02287636
PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer
A study testing fludeoxyglucose F 18, positron emission tomography and computed tomography in people with Childhood Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- fludeoxyglucose F 18, positron emission tomography and computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.
SECONDARY OBJECTIVES:
- 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
- Childhood Cancer
- Being tested
- fludeoxyglucose F 18, positron emission tomography, computed tomography, magnetic resonance imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo fludeoxyglucose F 18 PET/CT
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo fludeoxyglucose F 18 PET/CT
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo fludeoxyglucose F 18 PET/CT
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo PET/MRI
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) | Experimental | Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. Receives: Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography; Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (4)
SUVs Using PET/MRI
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Measured: 1 day
SUVs Using PET/CT
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Measured: 1 day
Radiation Dose Reduction Associated With PET/MRI
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Measured: 1 day
Time Effort Associated With the PET/MRI
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Bangert, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287636
- Sponsor's protocol ID
- CASE1Z13
- Other IDs
- NCI-2014-00828, CASE1Z13, CASE 1Z13, P30CA043703
- Status last verified
- Feb 2020
- First submitted
- 17 Apr 2014
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT02287636
- Acronym / sponsor ID
- CASE1Z13
- Conditions
- Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) | Experimental | Radiation: fludeoxyglucose F 18, Procedure: positron emission tomography, Procedure: computed tomography, Procedure: magnetic resonance imagingPatients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo fludeoxyglucose F 18 PET/CT | Radiation | Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo fludeoxyglucose F 18 PET/CT | Procedure or surgery | Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) |
| computed tomographyAlso: tomography, computedUndergo fludeoxyglucose F 18 PET/CT | Procedure or surgery | Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo PET/MRI | Procedure or surgery | Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo PET/MRI | Procedure or surgery | Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI) |
Primary outcome
Diagnostic Accuracy of PET/MRI
Time frame: 1 day
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.
Diagnostic Accuracy of PET/CT
Time frame: 1 day
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.
4 secondary outcomes
SUVs Using PET/MRI
Time frame: 1 day
SUVs Using PET/CT
Time frame: 1 day
Radiation Dose Reduction Associated With PET/MRI
Time frame: 1 day
Time Effort Associated With the PET/MRI
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Bangert principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fludeoxyglucose F 18, positron emission tomography and computed tomography in people with Childhood Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of PET/MRI (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.