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

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.

Study Overview

• Status: Unknown
• Conditions: Positron-Emission Tomography; Brain Neoplasms, Childhood
• Intervention / Treatment: Diagnostic test: 18F-FET PET

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisbeth Marner, MD PhD DMSc; Phone Number: 0045 35450968; Email: lisbeth.marner.01@regionh.dk
• Study Contact Backup: Name: Ian Law, MD PhD DMSc; Phone Number: 0045 35458513; Email: ian.law@regionh.dk

Study Locations

• Denmark
  • Copenhagen O
    • Copenhagen, Copenhagen O, Denmark, DK-2100
      • Recruiting
      • Copenhagen University Hospital Rigshospitalet
      • Contact: Lisbeth Marner, MD PhD DMSc; Phone Number: 0045 35450968; Email: lisbeth.marner.01@regionh.dk
      • Contact: Ian Law, MD PhD DMSc; Phone Number: 0045 35458513; Email: ian.law@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All included patients; A 18F-FET PET scan is performed	Diagnostic test: 18F-FET PET; Patient are investigated with an 18F-FET PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of treatment	The treatment plan is changed based on the PET findings	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recurrence free survival time	Comparison of PET better than MRI can predict the time before progression or recurrence	at least one year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Børnecancerfonden
• Investigators: Principal Investigator: Lisbeth Marner, MD PhD DMSc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2015
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: child; PET/MRI; FET
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 327-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No