The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents (BUF)
Primary Purpose
Positron-Emission Tomography, Brain Neoplasms, Childhood
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
18F-FET PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Positron-Emission Tomography focused on measuring FET, PET/MRI, child
Eligibility Criteria
Inclusion Criteria:
- Suspicion of newly diagnosed CNS tumor, recurrence or radiation therapy planning
- age <18 years at first CT/MRI suggesting CNS tumor
- written informed consent from parents (age < 18 years) or the patient (age >18 years)
Exclusion Criteria:
- contraindications for MRI (e.g. metal implants)
- pregnancy
- known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia
Sites / Locations
- Copenhagen University Hospital RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All included patients
Arm Description
A 18F-FET PET scan is performed
Outcomes
Primary Outcome Measures
Change of treatment
The treatment plan is changed based on the PET findings
Secondary Outcome Measures
Sensitivity and specificity
The sensitivity and specificity of PET/MRI is compared to MRI alone. The gold standard is clinical follow-up.
Recurrence free survival time
Comparison of PET better than MRI can predict the time before progression or recurrence
Full Information
NCT ID
NCT03402425
First Posted
May 1, 2017
Last Updated
March 26, 2019
Sponsor
Rigshospitalet, Denmark
Collaborators
Børnecancerfonden
1. Study Identification
Unique Protocol Identification Number
NCT03402425
Brief Title
The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents
Acronym
BUF
Official Title
The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2015 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Børnecancerfonden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the diagnostic value of 18F-FET PET/MRI instead of MRI alone, children and adolescents with tumor in brain or spinal cord are included and scanned primarily at our hybrid PET/MRI using the amino acid analog 18F-FET. The scans are performed at primary diagnosis, before radiation therapy, before and after operation, when relapse is suspected and three or six months after initiation of chemotherapy.
Detailed Description
Background. Tumors in the brain and spinal cord are among the most common causes of death and disability by cancer in children and adolescents. MRI is used for primary diagnosis as well as follow-up but is often challenged by tissue changes caused by the treatment. The amino acid analog 18F-FET is used increasingly in adults to delineate tumor and discriminate tumor from treatment effects. A hybrid PET/MRI scanner enables the simultaneous imaging with PET and MRI, which is important in especially the younger children needing anaesthesia to cooperate to the procedure.
Aim The aim of the study is to compare diagnostics using MRI alone with 18F-FET PET/MRI (or sequential MRI and PET) in children and adolescents diagnosed with a central nervous system (CNS) tumor before the age of 18 years. The scans will be performed at primary diagnosis/before operation/biopsy, within 72 hours after operation, planning radiation therapy, evaluation of treatment effect, when relapse is suspected.
Exclusion criteria are MRI contraindications, pregnancy, or a syndrome with increased sensitivity to radiation.
The investigators wish to evaluate which cases and for which tumor types, 18F-FET PET/MRI will increase sensitivity and specificity of diagnosing CNS tumors.
Side effects The side effects are mainly the side effect from the MRI with venous puncture, the MRI contrast leading that can lead to shortlived nausea or headache, fasting for 6 hours and the radioactivity exposure of 4.2 mSv (1,4 times the early background radiation) for each scan procedure. The maximal number of scans in the project is 3, 6 or 10 depending on the diagnosis.
Data Analysis The correlation between 18F-FET uptake in tumor and tumor grading (obtained from operation/biopsy) will be investigated.
When relapse is suspected, sensitivity and specificity for recurrence/progression for MRI alone versus PET/MRI will be compared.
It will be analysed if the addition of PET influences the diagnosis/chosen treatment. A major impact of 6% will be regarded significant.
The prognostic value of 18F-FET uptake after treatment will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positron-Emission Tomography, Brain Neoplasms, Childhood
Keywords
FET, PET/MRI, child
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We aim to include all patients that fullfil the inclusion criteria.
Masking
None (Open Label)
Masking Description
The result of the PET scan is masked until a treatment plan for the patient has been decided by the treatment responsible clinicians based on the MRI findings.
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All included patients
Arm Type
Experimental
Arm Description
A 18F-FET PET scan is performed
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FET PET
Intervention Description
Patient are investigated with an 18F-FET PET
Primary Outcome Measure Information:
Title
Change of treatment
Description
The treatment plan is changed based on the PET findings
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Sensitivity and specificity
Description
The sensitivity and specificity of PET/MRI is compared to MRI alone. The gold standard is clinical follow-up.
Time Frame
up to 3 months
Title
Recurrence free survival time
Description
Comparison of PET better than MRI can predict the time before progression or recurrence
Time Frame
at least one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspicion of newly diagnosed CNS tumor, recurrence or radiation therapy planning
age <18 years at first CT/MRI suggesting CNS tumor
written informed consent from parents (age < 18 years) or the patient (age >18 years)
Exclusion Criteria:
contraindications for MRI (e.g. metal implants)
pregnancy
known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisbeth Marner, MD PhD DMSc
Phone
0045 35450968
Email
lisbeth.marner.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Law, MD PhD DMSc
Phone
0045 35458513
Email
ian.law@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisbeth Marner, MD PhD DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Rigshospitalet
City
Copenhagen
State/Province
Copenhagen O
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisbeth Marner, MD PhD DMSc
Phone
0045 35450968
Email
lisbeth.marner.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Ian Law, MD PhD DMSc
Phone
0045 35458513
Email
ian.law@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents
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