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In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST)) can improve treatment for brain tumors through early detection of tumor progression after radiotherapy and/or chemotherapy treatment. An issue with the current treatment for patients with a brain tumor, is the inability to detect tumor progression early. An abnormality is seen on MRI scans taken shortly after treatment with radiotherapy in about 30% of patients. This abnormality may be a sign that radiotherapy treatment has worked well and will disappear on its own after a while. However, an abnormality can also be a sign of active tumor tissue. Then it shows that the treatment has not worked well enough. When there is active tumor tissue, this is called 'tumor progression'. When there is an abnormality that disappears on its own after a while, there is no active tumor tissue. This is called 'pseudoprogression'. Currently, there are two options to determine whether tumor progression or pseudoprogression has taken place: Do another brain surgery to see if the abnormality contains active tumor tissue or wait and have regular MRI scans until it is clear whether the abnormality goes away on its own. Amide proton transfer weighted chemical exchange saturation transfer (APTw-CEST) imaging is a new MRI technique in which investigators can produce images that show the accumulation of protein. APTw-CEST has previously been shown to be able to distinguish tumor progression from pseudoprogression earlier than current standard MRI scans. However, these previous studies have drawbacks: they were either done with a small group of patients in 1 hospital, or with a 7 Tesla MRI scanner, a rare type of scanner not standard in hospitals, or done in animal models. In this research project the investigators now want to prepare APTw-CEST for standard patient care for patients with glioblastoma in the Netherlands so that in the future APTw-CEST can be included as a standard scan during treatment. The investigators are doing this by introducing APTw-CEST MRI on the clinical MRI scanners of four different hospitals. Ultimately, the investigators want to use this to create national guidelines for measuring and viewing APTw-CEST MRI images for early detection of tumor progression.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT07121842 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Erasmus Medical Center |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Netherlands |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Glioblastoma |
| Study Website: | View Trial Website |
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