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Pretrained Resnet for surgical Outcome prediction using PET Hypometabolism and Excised Tissue (PROPHET)

Pretrained Resnet for surgical Outcome prediction using PET Hypometabolism and Excised Tissue (PROPHET) in participants planned for resective epilepsy surgery: Prospective Validation Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001085561
Enrollment
50
Registered
2024-09-09
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Epilepsy surgery is the best treatment option for people living with epilepsy that cannot be controlled with medication alone, also known as drug resistant epilepsy. In people living with drug resistant epilepsy, epilepsy surgery offers a better chance of stopping seizures than medications alone, however, not all patients who have epilepsy surgery become seizure free. Many research studies that have tried to understand why some patients do not become seizure free after epilepsy surgery have focused on population data rather than looking at patients on an individual level. We have developed a tool that uses machine learning, a form of artificial intelligence, to make a personalised prediction of the outcome following epilepsy surgery. In its development, this tool used the brain imaging (magnetic resonance imaging [MRI] and positron emission tomography [PET] scans), as well as the actual surgical area, of patients who have already had epilepsy surgery. The aim of this study is to assess the accuracy of the tool when using the intended/ planned surgery in place of the actual resection region.

Interventions

This is a prospective cohort study of patients who are undergoing resective epilepsy surgery for drug resistant epilepsy, designed to prospectively validate the clinical tool PROPHET, which predicts outcome following epilepsy surgery. PROPHET is a deep-learning based tool that utilises the preoperative T1-weighted MRI, preoperative 18F-FDG-PET scan, and a mask of the resection region as inputs to develop a predicted classification of the outcome following epilepsy surgery (Engel 1 vs Engel 2-4).

This is a prospective cohort study of patients who are undergoing resective epilepsy surgery for drug resistant epilepsy, designed to prospectively validate the clinical tool PROPHET, which predicts outcome following epilepsy surgery. PROPHET is a deep-learning based tool that utilises the preoperative T1-weighted MRI, preoperative 18F-FDG-PET scan, and a mask of the resection region as inputs to develop a predicted classification of the outcome following epilepsy surgery (Engel 1 vs Engel 2-4). PROPHET was developed by our team using retrospective data, and in model development, the mask of the resection region was generated from the difference map between the preoperative and postoperative T1-weighted MRIs, and therefore represented the actual resection region. However, to be clinically useful prior to epilepsy surgery, this tool will use a mask of the intended resection region in place of the actual resection region. For all participants in this study, the intended resection region will be annotated manually prior to epilepsy surgery using brain imaging software such as ITK-SNAP or BrainLab. A prediction of the surgical outcome will be subsequently generated using the annotated intended resection region, preoperative MRI and preoperative PET (Model A). The predicted outcome generated by PROPHET will not be re-identified with study participants. Therefore, it will not be disclosed to the treating epileptologist or neurosurgeon prior to, or following, epilepsy surgery. The predicted outcome generated by PROPHET will not impact the clinical decision making about whether the patient will proceed to epilepsy surgery or the nature operation to be performed. The PROPHET predicted outcome will also not be shared with the participant. We will subsequently observe the actual surgical outcome following epilepsy surgery up to 12 months, as measured by the Engel Surgical Outcome Scale. We will also collect the postoperative MRI in the subset of subjects for whom a postoperative MRI was acquired for clinical purposes. The actual resection region will be generated for all patients who have a postoperative MRI, by generating a difference map between the preoperative and postoperative MRI (using the same method as in PROPHET development). Model B will be a repeat prediction using the preoperative MRI, preoperative PET and actual resection region. For both models (model A using the intended resection region, and model B the actual resection region), the predicted Engel outcome and the actual Engel outcomes will be compared using area under the receiver operator characteristic (AUC) to validate the model.

Sponsors

Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The participant can provide informed consent on their own behalf. 2. The participant is planned for resective epilepsy surgery (either temporal or extratemporal surgery). 3. A preoperative volumetric T1-weighted brain MRI is available. 4. A preoperative brain 18F-FDG-PET scan is available. 5. The participant is fluent in English. 6. The participant is eligible for Medicare

Exclusion criteria

1. Age less than or equal to 17 years old 2. Prior resective epilepsy surgery 3. Non-resective epilepsy surgeries, such as laser interstitial thermal therapy (LITT), vagus nerve stimulator (VNS) implantation, deep brain stimulator (DBS) implantation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026