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NCT06657027Not yet recruiting

Artificial Intelligence-Guided Radiotherapy Planning for Glioblastoma

Evaluation of the Efficacy and Safety of Personalized Radiotherapy Guided by Predictive Models of Tumor Infiltration, Combining Artificial Intelligence and Multiparametric MRI in Glioblastomas

Source: ClinicalTrials.gov · Last updated 24 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
15 Oct 2024
Start date
1 Jan 2025
Primary completion date
31 Dec 2026
Lead sponsor
Hospital del Rio Hortega
NCT number
NCT06657027

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of pacemakers, neurostimulators, cochlear implants, metal in ocular structures, or work history that compromise safety in MRI.
  • Previous treatments with cytotoxic, noncytotoxic, experimental agents, or cranial radiation therapy.
  • Maximum radiation target volume (GTV3) greater than 65 cc.

Other illness

  • Significant medical illnesses that may compromise tolerance to treatment, at the discretion of the investigator.
  • History of invasive cancer in the last 3 years, with few exceptions.
  • Active infections or serious intercurrent illnesses.

Who the study is looking for

  • Patients with a recent diagnosis of IDH wild-type glioblastoma, grade 4 according to the Central Nervous System Tumors classification of the World Health Organization of 2021.
  • Ability to undergo MRI studies.
  • Performance status with Karnofsky Performance Status (KPS) ≥ 60.
  • Life expectancy ≥ 12 weeks.
  • Laboratory results within the following ranges, obtained in the 14 days prior to enrollment:
    • Leucocitos ≥ 3,000/µL.
    • Absolute neutrophils ≥ 1,500/µL.
    • Plaquetas ≥ 75,000/µL.
    • Hemoglobin ≥ 9.0 g/dL (transfusion is allowed to reach the minimum level).
    • Glutamic-oxaloacetic transaminase (SGOT) ≤ 2 times the upper limit of normal.
    • Bilirubin ≤ 2 times the upper limit of normal.
    • Creatinina ≤ 1.5 mg/dL.
  • Women of childbearing age must present a negative pregnancy test ≤ 14 days prior to enrollment.
  • Ability to understand and sign the informed consent.
  • Willingness to refrain from other cytotoxic or noncytotoxic therapies against the tumor during the protocol.

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.