FET-PET-Guided Management of Pseudoprogression in Glioblastoma
NCT ID: NCT06480721
Last Updated: 2024-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
144 participants
INTERVENTIONAL
2024-08-31
2027-12-31
Brief Summary
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The main questions it aims to answer are:
* Does the clinical management guided by an additional FET-PET scan leads to fewer unnecessary interventions, compared with management based on MRI only?
* Does the clinical management guided by an additional FET-PET scan leads to better health-related quality of life after 12 weeks, compared with management based on MRI only?
* Does the clinical management guided by an additional FET-PET scan leads to reduced net healthcare costs, compared with management based on MRI only?
Researchers will compare the investigational arm, where clinical management is based on the index MRI scan and an additional FET-PET scan, with the control arm, where clinical management is based solely on the index MRI scan, to investigate the added value of the FET PET scan for clinical management.
Participants in the investigational arm will undergo the FET PET scan. All participants will complete health-related quality of life questionnaires at four different timepoints.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Clinical management is based on the index MRI and an additional [¹⁸F] FET-PET together
Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan
Patients in the investigational arm will undergo the extra FET-PET scan, with use of the O-(2-
¹⁸F-fluoroethyl)-L-tyrosine (¹⁸F-FET) tracer. FET-PET scanning will be performed according to the joint European Association of Nuclear Medicine (EANM)/European Association of Neuro-Oncology (EANO)/Response Assessment in Neuro-oncology (RANO) guidelines. In most patients, a static scan (20-40 minutes post-injection) will performed. If the logistics of the research site allow for a dynamic scan (0-60 minutes post-injection), this will be performed. Interpretation will be done by an experienced nuclear medicine physician from the local center according to current European guidelines. Central review will be performed by a panel of nuclear medicine physicians from the study team. Clinical management is based on the index MRI and this additional \[¹⁸F\] FET PET scan.
Standard of care
No interventions assigned to this group
Interventions
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Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan
Patients in the investigational arm will undergo the extra FET-PET scan, with use of the O-(2-
¹⁸F-fluoroethyl)-L-tyrosine (¹⁸F-FET) tracer. FET-PET scanning will be performed according to the joint European Association of Nuclear Medicine (EANM)/European Association of Neuro-Oncology (EANO)/Response Assessment in Neuro-oncology (RANO) guidelines. In most patients, a static scan (20-40 minutes post-injection) will performed. If the logistics of the research site allow for a dynamic scan (0-60 minutes post-injection), this will be performed. Interpretation will be done by an experienced nuclear medicine physician from the local center according to current European guidelines. Central review will be performed by a panel of nuclear medicine physicians from the study team. Clinical management is based on the index MRI and this additional \[¹⁸F\] FET PET scan.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* New or increased enhancement within the high-dose radiation field (defined as within the 80% isodose line) on follow-up MRI
* First moment of clinicoradiological uncertainty regarding the diagnosis (≥3 months after the end of chemoradiation): pseudoprogression or tumor recurrence. The determination of 'uncertainty' is made by the treating physician, preferably in the multidisciplinary tumor board, based on available clinical and standard-of-care MRI-data, which generally includes perfusion-MRI.
* Previous usage of bevacizumab as a symptom treatment is allowed. However, inclusion is only allowed at the first moment of clinical doubt between pseudoprogression and tumor recurrence, not at later timepoints.
Exclusion Criteria
* An enhanced lesion size of less than 1 cm on the index MRI. In the newest RANO PET criteria, it is advised to use FET-PET for increasing lesions only in cases with a minimum lesion size.
* Life expectancy of less than 6 months, determined by the treating physician
* Contra-indications for PET (claustrophobia, inability to lay still)
* Women of childbearing potential without adequate contraception
* Any other concomitant disease that may influence PET imaging or clinical outcomes of this study, this includes but is not limited to: cerebral inflammatory diseases and other cancers with brain- or leptomeningeal metastases
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Curium PET France
INDUSTRY
Veerle Ruijters
OTHER
Responsible Party
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Veerle Ruijters
Medical researcher
Principal Investigators
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Tom J Snijders, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Nelleke Tolboom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
UMC Groningen
Groningen, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haaglanden MC
The Hague, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Elsmarieke M van de Giessen, MD, PhD
Role: primary
Dylan JH Henssen, MD, PhD
Role: primary
Sophie EM Veldhuijzen van Zanten, MD, PhD
Role: primary
Maaike J Vos, MD, PhD
Role: primary
Veerle J Ruijters, MD
Role: primary
N Tolboom, MD, PhD
Role: backup
References
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Ruijters VJ, Snijders TJ, van der Pol JAJ, van de Giessen EM, Niers JM, Broen MPG, Anten MM, van Zanten SEMV, Geurts M, Arens AIJ, Henssen DJHA, Gijtenbeek JM, van der Meulen M, Sijben AEJ, Ghariq E, Vos MJ, Tim J, Bosma IB, Stormezand GN, Frederix GWJ, Dankbaar JW, Robe PA, Verhoeff JJC, de Vos FYFL, Lam MGEH, Ten Ham RMT, Tolboom N. [18F]FET PET-Guided management of pseudoprogression in glioblastoma (FET POPPING): the study protocol for a diagnostic randomized clinical trial. Trials. 2025 Jun 17;26(1):208. doi: 10.1186/s13063-025-08921-8.
Other Identifiers
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10390022210022
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NL86008.041.24
Identifier Type: -
Identifier Source: org_study_id