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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03402425
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Lisbeth Marner, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Positron-Emission Tomography Brain Neoplasms, Childhood Diagnostic Test: 18F-FET PET Not Applicable

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.

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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.
Primary Purpose: Diagnostic
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

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

Primary Outcome Measures :
  1. Change of treatment [ Time Frame: up to 3 months ]
    The treatment plan is changed based on the PET findings

Secondary Outcome Measures :
  1. 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.

  2. Recurrence free survival time [ Time Frame: at least one year ]
    Comparison of PET better than MRI can predict the time before progression or recurrence

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03402425

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Contact: Lisbeth Marner, MD PhD DMSc 0045 35450968
Contact: Ian Law, MD PhD DMSc 0045 35458513

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Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Copenhagen O, Denmark, DK-2100
Contact: Lisbeth Marner, MD PhD DMSc    0045 35450968   
Contact: Ian Law, MD PhD DMSc    0045 35458513   
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Lisbeth Marner, MD PhD DMSc Rigshospitalet, Denmark

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Responsible Party: Lisbeth Marner, MD, PhD, DMSc, Staff Specialist, Rigshospitalet, Denmark Identifier: NCT03402425     History of Changes
Other Study ID Numbers: 327-15
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisbeth Marner, Rigshospitalet, Denmark:
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases