Positron-Emission TomographyBUFNCT03402425
The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents
A study testing 18F-FET PET in people with Positron-Emission Tomography and Brain Neoplasms, Childhood, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Positron-Emission Tomography, Brain Neoplasms, Childhood
- What is being tested?
- 18F-FET PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Feb 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- contraindications for MRI (e.g. metal implants)
- pregnancy
- known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Rigshospitalet
Copenhagen, Copenhagen O, DK-2100
Lisbeth Marner, MD PhD DMSc, 0045 35450968, lisbeth.marner.01@regionh.dk
Ian Law, MD PhD DMSc, 0045 35458513, ian.law@regionh.dk
About this study
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.
Read the 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.
- Being tested
- 18F-FET PET
- Keywords
- FET, PET/MRI, child
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FET PETDiagnostic test
Patient are investigated with an 18F-FET PET
| Study group | Role | What they receive |
|---|---|---|
| All included patients | Experimental | A 18F-FET PET scan is performed Receives: Diagnostic Test: 18F-FET PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of treatment
The treatment plan is changed based on the PET findings
Measured: up to 3 months
Secondary outcomes (2)
Sensitivity and specificity
The sensitivity and specificity of PET/MRI is compared to MRI alone. The gold standard is clinical follow-up.
Measured: up to 3 months
Recurrence free survival time
Comparison of PET better than MRI can predict the time before progression or recurrence
Measured: at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start24 Feb 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We aim to include all patients that fullfil the inclusion criteria.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Børnecancerfonden
- Responsible party
- Principal investigator, Lisbeth Marner, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lisbeth Marner, MD PhD DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402425
- Sponsor's protocol ID
- 327-15
- Acronym
- BUF
- Status last verified
- Mar 2019
- First submitted
- 1 May 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03402425
- Acronym / sponsor ID
- BUF / 327-15
- Keywords
- FET, PET/MRI, child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Børnecancerfonden
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We aim to include all patients that fullfil the inclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| All included patients | Experimental | Diagnostic Test: 18F-FET PETA 18F-FET PET scan is performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- contraindications for MRI (e.g. metal implants)
- pregnancy
- known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FET PETPatient are investigated with an 18F-FET PET | Diagnostic test | All included patients |
Primary outcome
Change of treatment
Time frame: up to 3 months
The treatment plan is changed based on the PET findings
2 secondary outcomes
Sensitivity and specificity
Time frame: up to 3 months
Recurrence free survival time
Time frame: at least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisbeth Marner, MD PhD DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FET PET in people with Positron-Emission Tomography and Brain Neoplasms, Childhood, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisbeth Marner, MD PhD DMSc (0045 35450968, lisbeth.marner.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of treatment (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.