Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623565
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Extensive Resection of Malignant Brain Tumors Using Advanced Imaging Techniques
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Image-guided Resection of IDH Wildtype Glioblastoma and Grade IV IDH-mutant Astrocytoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEXTFRONTIER
Brief Summary:
Rationale Patients with IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma have a very poor prognosis despite standard treatment consisting of surgery radiotherapy and chemotherapy Diffuse infiltration of the brain by the tumor is thought to be one of the main causes of this therapy-resistance In order to improve the surgical treatment tumor regions with lower infiltration percentages need to be identified and resected during surgery a so-called supramarginal resection Currently pre-operative T1 contrast enhanced weighted T1c MRI is used to identify the tumor for resection We recently found the combination of apparent diffusion coefficient MRI and O-2- 18Ffluoroethyl--L-tyrosine positron emission tomography ADCFET to be significantly more accurate than T1c MRI alone in the detection of tumor infiltration This makes ADCFET a suitable candidate to guide supramarginal resection Since FET PET is not as accessible and widely available as MRI identification of an MRI based alternative could result in a more widespread implementation Amide proton transfer chemical exchange saturation transfer APT-CEST MRI is a novel potential alternative for FET PET since both measures are related to protein content
Objective In this project we aim to develop a safe and effective technique for ADCFET guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma The safety concerns neurological deficits and time to start of adjuvant therapy while the effectiveness is aimed at the extent of resection Our secondary aim is to evaluate the diagnostic accuracy of APT-CEST MRI and to assess whether APT-CEST MRI can serve as an alternative for FET PET for the detection of tumor infiltration
Study design prospective observational intervention study
Study population 30 patients with clinical and radiological diagnosis of an untreated high grade glioma suspected for glioblastoma IDH wildtype or grade IV astrocytoma IDH mutant who are eligible for a supramarginal surgical resection and adjuvant treatment according two neurosurgeons in consensus and who are in relatively good condition Karnofsky Performance Score KPS 70
Intervention if applicable supramarginal ADCFET-guided resection To make sure that the standard treatment is always guaranteed T1c MRI abnormalities will be included in the surgical target
Main study parametersendpoints the main study endpoint is the optimization of ADCFET-guided resection Volumetric and percentual extent of resection as measured with MRI and PET imaging combined with surgery-induced morbidity will be used as outcome parameters The secondary study parameters will be the histopathology-based diagnostic accuracy of APT-CEST MRI in comparison with FET PET cognitive performance over time and progression free survival
Nature and extent of the burden and risks associated with participation benefit and group relatedness participants will undergo pre- and postoperative MRI scanning This is also part of regular clinical care except there are additional MRI sequences including APT CEST in the pre-operative and pre-radiotherapy MRI There are no risks associated with MRI acquisition after MRI safety screening Participants will furthermore undergo a pre- and postoperative FET PET The risks associated with PET scanning are limited and the radiation burden will remain below 10 mSv ICRP62 category intermediate risk level IIb During surgery biopsies are performed from areas that will be resected so these biopsies will not introduce any extra risk A potential benefit is the possibility of the removal of more tumor tissue A potential risk is the additional removal of healthy brain tissue with the risk of neurological damage which is controlled by pre- and intraoperative techniques such as visualization of white matter tracts and mapping both asleep and awake of critical functions such as language and control of strength
Objective In this project we aim to develop a safe and effective technique for ADCFET guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma The safety concerns neurological deficits and time to start of adjuvant therapy while the effectiveness is aimed at the extent of resection Our secondary aim is to evaluate the diagnostic accuracy of APT-CEST MRI and to assess whether APT-CEST MRI can serve as an alternative for FET PET for the detection of tumor infiltration
Study design prospective observational intervention study
Study population 30 patients with clinical and radiological diagnosis of an untreated high grade glioma suspected for glioblastoma IDH wildtype or grade IV astrocytoma IDH mutant who are eligible for a supramarginal surgical resection and adjuvant treatment according two neurosurgeons in consensus and who are in relatively good condition Karnofsky Performance Score KPS 70
Intervention if applicable supramarginal ADCFET-guided resection To make sure that the standard treatment is always guaranteed T1c MRI abnormalities will be included in the surgical target
Main study parametersendpoints the main study endpoint is the optimization of ADCFET-guided resection Volumetric and percentual extent of resection as measured with MRI and PET imaging combined with surgery-induced morbidity will be used as outcome parameters The secondary study parameters will be the histopathology-based diagnostic accuracy of APT-CEST MRI in comparison with FET PET cognitive performance over time and progression free survival
Nature and extent of the burden and risks associated with participation benefit and group relatedness participants will undergo pre- and postoperative MRI scanning This is also part of regular clinical care except there are additional MRI sequences including APT CEST in the pre-operative and pre-radiotherapy MRI There are no risks associated with MRI acquisition after MRI safety screening Participants will furthermore undergo a pre- and postoperative FET PET The risks associated with PET scanning are limited and the radiation burden will remain below 10 mSv ICRP62 category intermediate risk level IIb During surgery biopsies are performed from areas that will be resected so these biopsies will not introduce any extra risk A potential benefit is the possibility of the removal of more tumor tissue A potential risk is the additional removal of healthy brain tissue with the risk of neurological damage which is controlled by pre- and intraoperative techniques such as visualization of white matter tracts and mapping both asleep and awake of critical functions such as language and control of strength
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None