An observational study in Glioblastoma, sponsored by Hospital del Rio Hortega. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Hospital del Rio Hortega · Observational
The ARTPLAN-GLIO study aims to evaluate the feasibility and effectiveness of integrating artificial intelligence in personalized radiotherapy planning for glioblastomas. On the basis of previous work by our group, where a predictive model was developed from radiological characteristics extracted from MR images, this project will evaluate the use of tumor infiltration probability maps in radiotherapy planning.
Currently, radiotherapy treatment uses margins defined by population studies, without considering the individual characteristics of the patients. Although 80% of recurrences occur in peritumoral areas close to the surgical margins, treatment volumes are not customized owing to the lack of techniques that distinguish between edema and infiltrated tumor tissue.
Our recurrence probability maps address this limitation and could improve radiation planning. In this study, the volumes and doses of radiotherapy were adjusted according to the predictions of the model, with a focus on high-risk areas to optimize local control and reduce toxicity in healthy tissues.
Survival results will be compared between patients treated with personalized AI-guided radiotherapy and a historical cohort with standard treatment. In addition, the safety of the approach will be evaluated by adverse event analysis. Finally, an accessible online platform with the potential to transform glioblastoma treatment and improve patient survival will be developed to implement this predictive model.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 208 observational studies indexed under Glioblastoma.
Browse Glioblastoma studies →Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients with newly diagnosed IDH wild-type glioblastoma, grade 4, as classified by the World Health Organization (WHO) 2021 Central Nervous System Tumor guidelines. Eligible participants must have undergone maximum safe tumor resection and be scheduled to receive radiotherapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory results within the following ranges, obtained in the 14 days prior to enrollment:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes patients with newly diagnosed IDH wild-type glioblastoma, grade 4, according to the 2021 WHO classification of Central Nervous System Tumors. Patients in this group will undergo personalized radiotherapy guided by artificial intelligence (AI) and multiparametric MRI, using predictive models to adjust treatment volumes and doses according to areas of tumor infiltration. The AI model, developed from radiomic characteristics of postoperative MRI, predicts tumor recurrence and infiltration, enabling targeted dose escalation to high-risk areas while minimizing radiation exposure to healthy tissues.
Feasibility of AI-Guided Radiotherapy for Glioblastoma
The primary outcome of the study is to assess the feasibility of integrating an AI-based predictive model into radiotherapy planning for patients with glioblastoma. The model uses radiomic features derived from multiparametric MRI to generate tumor infiltration probability maps, which guide the personalized adjustment of treatment volumes and doses. Feasibility will be determined by evaluating the successful integration of the AI model into clinical practice, the precision of the model in identifying areas of tumor infiltration, and the ability to implement personalized treatment plans in a routine clinical setting.
Time frame: 12 months after the start of radiotherapy for the last enrolled patient.
Progression-Free Survival (PFS) at 1 Year
This outcome evaluates whether patients treated with personalized AI-guided radiotherapy experience improved progression-free survival (PFS) at one year compared to a historical control group treated with standard radiotherapy. PFS is defined as the time from the start of radiotherapy to either the first documented disease progression or death from any cause. The AI-guided approach uses tumor infiltration probability maps to target high-risk areas, aiming to delay or prevent local recurrence.
Time frame: 12 months after the start of radiotherapy for each patient.
Overall Survival (OS)
This outcome measures the overall survival (OS) of patients treated with AI-guided personalized radiotherapy for glioblastoma. OS is defined as the time from the start of radiotherapy to death from any cause. The study aims to assess whether personalized radiotherapy, guided by AI-driven tumor infiltration probability maps, improves survival outcomes compared to standard radiotherapy. This will be evaluated by comparing OS in the AI-guided group with a historical control group treated with standard radiotherapy protocols.
Time frame: 24 months after the start of radiotherapy for each patient.
Quality of Life
This outcome evaluates the differences in quality of life (QoL) between patients treated with AI-guided radiotherapy based on multiparametric MRI and those treated with standard radiotherapy (historical controls). Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: 12 months after the start of radiotherapy for each patient.
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hospital del Rio Hortega