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

Positron-Emission Tomography Clinical Trial

— BUF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402425
• Other study ID #: 327-15
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Rigshospitalet, Denmark
• Contact: Lisbeth Marner, MD PhD DMSc
• Phone: 0045 35450968
• Email: lisbeth.marner.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Neoplasms, Childhood
• Positron-Emission Tomography

Intervention

Diagnostic Test:
• 18F-FET PET
Patient are investigated with an 18F-FET PET

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Rigshospitalet	Copenhagen	Copenhagen O

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Børnecancerfonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of treatment	The treatment plan is changed based on the PET findings	up to 3 months
Secondary	Sensitivity and specificity	The sensitivity and specificity of PET/MRI is compared to MRI alone. The gold standard is clinical follow-up.	up to 3 months
Secondary	Recurrence free survival time	Comparison of PET better than MRI can predict the time before progression or recurrence	at least one year