Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183983
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-12
Brief Title:
Hitting the Mark Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Hitting the Mark Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-01
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:
MOSAIC
Brief Summary:
The goal of this prospective cohort study is to assess the potential of advanced MRI for improved radiotherapy target delineation in patients diagnosed with glioblastoma The main questions it aims to answer are
How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan
How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan
Participants will undergo an extended MRI-protocol prior to radiotherapy This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences Radiation treatment and patient follow-up will occur according to the clinical standard
How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan
How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan
Participants will undergo an extended MRI-protocol prior to radiotherapy This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences Radiation treatment and patient follow-up will occur according to the clinical standard
Detailed Description:
Rationale One of the fundamentals of glioblastoma management is radiotherapy where ionizing radiation is aimed towards a specific target area in the brain to inhibit further tumor growth As these brain tumors are notorious for their extensive tumor infiltration where tumor grows beyond the tumor that is visible on conventional magnetic resonance imaging MRI this target area defined as the clinical target volume CTV consists of the visible tumor plus a 15-cm isotropic safety margin In the majority of cases this unspecific CTV margin adequately covers tumor infiltration but inevitably also includes considerable amounts of healthy tissue Radiation-induced side-effects like headaches nausea fatigue and cognitive decline can substantially affect the quality of life for these patients
An opportunity arises to indirectly visualize tumor infiltration with state-of-the-art advanced MRI aMRI techniques providing additional information on physiology rather than only showing anatomical information through conventional MRI A workflow has been developed to create a CTV based on these aMRI scans CTVaMRI rather than an isotropic expansion With the additional information that aMRI provides it could be possible to more accurately define what needs to be targeted and thus minimize damage to healthy tissue In this research the aim is to assess the potential of integrating aMRI into radiotherapy target delineation for patients with a glioblastoma by comparing the pattern of failure coverage of radiological tumor recurrence by the radiotherapy plan and the expected radiation dose to organs at risk between the CTVaMRI and the 15-cm CTV It is hypothesized that the CTVaMRI can result in decreased radiation dose to organs at risk whilst having similar pattern of failure
Primary objective To demonstrate that the probability for reduced coverage of the recurrence volume by a radiotherapy plan based on a CTVaMRI compared to the clinical radiotherapy plan 15-cm CTV is lower than 020
Secondary objective
To illustrate a reduction in dose to organs at risk with a radiotherapy plan based on a conceptual CTVaMRI compared to the clinical radiotherapy plan 15-cm CTV
To evaluate the synergistic information that each individual aMRI-scan provides for the identification of tumor infiltration
To explore the association between pathophysiological changes on aMRI and future tumor recurrence
Study design In this prospective cohort study the clinical standard MRI session used for radiotherapy planning of glioblastoma patients will be extended with aMRI techniques that assess altered oxygenation angiogenesis and increased protein concentration Radiation treatment and patient follow-up will occur according to the clinical standard ie using the 15-cm CTV for radiotherapy planning The aMRI-scans will be used to create a theoretical CTVaMRI and corresponding radiotherapy plan Pattern-of-failure analysis and assessment of dose to organs at risk will be done to compare the radiotherapy plan based on the 15-cm CTV with the theoretical radiotherapy plan based on the CTVaMRI Additionally various theoretical CTVs based on different combinations of aMRI-scans are generated to explore the added value of the different aMRI techniques Lastly the signal intensities on the aMRI-scans at the site of tumor recurrence are compared with contralateral normal-appearing white matter
Study population Patients 18 years diagnosed with IDH-wildtype glioblastoma as confirmed by molecular or immunohistochemistry analysis post resectionbiopsy and referred to outpatient clinic of the Department of Radiotherapy to undergo standard treatment with radiotherapy The inclusion comes to an end when 53 patients have been included
Intervention Each patient will have an extension to their standard radiotherapy planning MRI-scan taken for regular clinical care Brain tumor MRI protocol 25 minutes The duration of the extended MRI-scan which includes the brain tumor MRI protocol is 45 minutes
Main study parametersendpoints Pattern of failure and dose to organs at risk by the radiotherapy plan based on the 15-cm CTV and the theoretical plan created with the CTVaMRI
Nature and extent of the burden and risks associated with participation benefit and group relatedness The patients have the burden of prolonged scan time 20 minutes scan will last at maximum 60 minutes in total during their standard radiotherapy planning MRI-scan The remainder of their clinical care will not be altered Radiotherapy will be given to these patients based on standard 15-cm CTVs Follow-up will follow the clinical protocol There will be no personal benefit for the patients in this research project
An opportunity arises to indirectly visualize tumor infiltration with state-of-the-art advanced MRI aMRI techniques providing additional information on physiology rather than only showing anatomical information through conventional MRI A workflow has been developed to create a CTV based on these aMRI scans CTVaMRI rather than an isotropic expansion With the additional information that aMRI provides it could be possible to more accurately define what needs to be targeted and thus minimize damage to healthy tissue In this research the aim is to assess the potential of integrating aMRI into radiotherapy target delineation for patients with a glioblastoma by comparing the pattern of failure coverage of radiological tumor recurrence by the radiotherapy plan and the expected radiation dose to organs at risk between the CTVaMRI and the 15-cm CTV It is hypothesized that the CTVaMRI can result in decreased radiation dose to organs at risk whilst having similar pattern of failure
Primary objective To demonstrate that the probability for reduced coverage of the recurrence volume by a radiotherapy plan based on a CTVaMRI compared to the clinical radiotherapy plan 15-cm CTV is lower than 020
Secondary objective
To illustrate a reduction in dose to organs at risk with a radiotherapy plan based on a conceptual CTVaMRI compared to the clinical radiotherapy plan 15-cm CTV
To evaluate the synergistic information that each individual aMRI-scan provides for the identification of tumor infiltration
To explore the association between pathophysiological changes on aMRI and future tumor recurrence
Study design In this prospective cohort study the clinical standard MRI session used for radiotherapy planning of glioblastoma patients will be extended with aMRI techniques that assess altered oxygenation angiogenesis and increased protein concentration Radiation treatment and patient follow-up will occur according to the clinical standard ie using the 15-cm CTV for radiotherapy planning The aMRI-scans will be used to create a theoretical CTVaMRI and corresponding radiotherapy plan Pattern-of-failure analysis and assessment of dose to organs at risk will be done to compare the radiotherapy plan based on the 15-cm CTV with the theoretical radiotherapy plan based on the CTVaMRI Additionally various theoretical CTVs based on different combinations of aMRI-scans are generated to explore the added value of the different aMRI techniques Lastly the signal intensities on the aMRI-scans at the site of tumor recurrence are compared with contralateral normal-appearing white matter
Study population Patients 18 years diagnosed with IDH-wildtype glioblastoma as confirmed by molecular or immunohistochemistry analysis post resectionbiopsy and referred to outpatient clinic of the Department of Radiotherapy to undergo standard treatment with radiotherapy The inclusion comes to an end when 53 patients have been included
Intervention Each patient will have an extension to their standard radiotherapy planning MRI-scan taken for regular clinical care Brain tumor MRI protocol 25 minutes The duration of the extended MRI-scan which includes the brain tumor MRI protocol is 45 minutes
Main study parametersendpoints Pattern of failure and dose to organs at risk by the radiotherapy plan based on the 15-cm CTV and the theoretical plan created with the CTVaMRI
Nature and extent of the burden and risks associated with participation benefit and group relatedness The patients have the burden of prolonged scan time 20 minutes scan will last at maximum 60 minutes in total during their standard radiotherapy planning MRI-scan The remainder of their clinical care will not be altered Radiotherapy will be given to these patients based on standard 15-cm CTVs Follow-up will follow the clinical protocol There will be no personal benefit for the patients in this research project
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