The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03402425
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rigshospitalet, Denmark
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisbeth Marner, MD PhD DMSc
Principal Investigator Affiliation	Rigshospitalet, Denmark
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Positron-Emission Tomography, Brain Neoplasms, Childhood

Additional Details

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.

Arms & Interventions

Arms

Experimental: All included patients

A 18F-FET PET scan is performed

Interventions

Diagnostic Test: - 18F-FET PET

Patient are investigated with an 18F-FET PET

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