Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
FET-PET-Guided Management of Pseudoprogression in Glioblastoma
Sponsor:
Veerle Ruijters
Organization:
UMC Utrecht
Study Overview
Official Title:
FET-PET-Guided Management of Pseudoprogression in Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FET-POPPING
Brief Summary:
The goal of this diagnostic randomised clinical trial is to determine in glioblastoma patients with diagnostic uncertainty between pseudoprogression and tumor progression on follow-up MRI after chemoradiation the added value of a direct ¹⁸F FET-PET scan for clinical management
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
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:
During follow-up of glioblastoma patients after chemoradiation expert teams often observe MRI abnormalities with difficulty in distinguishing between tumor growth and pseudoprogression Although techniques such as perfusion MRI provide additional information diagnostic uncertainty often remains leading to incorrect or delayed diagnosis and inappropriate treatment such as unnecessary surgery Despite the good discriminating power of ¹⁸F Fluoro-ethyl-tyrosine-PET FET-PET this diagnostic tool is not used frequently in the Netherlands due to costs logistics and misconceptions about clinical benefit In the FET POPPING study we aim to determine the added value of ¹⁸F FET-PET for clinical management A multicenter diagnostic randomised clinical trial will be performed from July 2024 until December 2027 144 adult patients with isocitrate dehydrogenase IDH-wildtype glioblastoma will be included who after the concomitant phase of chemoradiation have increased contrast enhancement on MRI causing doubt between tumor growth or pseudoprogression Included patients will be randomised 11 in two arms The investigational arm receives an additional ¹⁸F FET-PET scan and clinical management is based on the index MRI and ¹⁸F FET-PET together Clinical management of the control arm is based on the index MRI alone Exact clinical management following from the available imaging is chosen at the discretion of a multidisciplinary board The primary study endpoints are a the percentage of patients undergoing unnecessary interventions and b health-related quality of life after 12 weeks Secondary endpoints include time-to-diagnosis overall survival and cost-effectiveness We hypothesize that the clinical management guided by an additional ¹⁸F FET-PET scan leads to fewer unnecessary interventions better health-related quality of life after 12 weeks and among others reduced net healthcare costs compared with management based on MRI only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10390022210022 | OTHER_GRANT | None | None |