The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents (BUF)
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|ClinicalTrials.gov Identifier: NCT03402425|
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Positron-Emission Tomography Brain Neoplasms, Childhood||Diagnostic Test: 18F-FET PET||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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.|
|Official Title:||The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents|
|Actual Study Start Date :||February 24, 2015|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: All included patients
A 18F-FET PET scan is performed
Diagnostic Test: 18F-FET PET
Patient are investigated with an 18F-FET PET
- Change of treatment [ Time Frame: up to 3 months ]The treatment plan is changed based on the PET findings
- Sensitivity and specificity [ Time Frame: up to 3 months ]The sensitivity and specificity of PET/MRI is compared to MRI alone. The gold standard is clinical follow-up.
- Recurrence free survival time [ Time Frame: at least one year ]Comparison of PET better than MRI can predict the time before progression or recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402425
|Contact: Lisbeth Marner, MD PhD DMSc||0045 firstname.lastname@example.org|
|Contact: Ian Law, MD PhD DMSc||0045 email@example.com|
|Copenhagen University Hospital Rigshospitalet||Recruiting|
|Copenhagen, Copenhagen O, Denmark, DK-2100|
|Contact: Lisbeth Marner, MD PhD DMSc 0045 35450968 firstname.lastname@example.org|
|Contact: Ian Law, MD PhD DMSc 0045 35458513 email@example.com|
|Principal Investigator:||Lisbeth Marner, MD PhD DMSc||Rigshospitalet, Denmark|