SIMPLIFication of Care Pathways for Patients with Rare Brain Tumors Through Artificial Intelligence

Not Applicable

Recruiting

• Conditions: Brain Tumors

• Registration Number: NCT06878469
• Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief Summary

This study focuses on rare brain tumors, which are heterogeneous entities with different morphological, biological, and clinical characteristics. Due to their rarity, many of these tumors fall under the RARECARE definition of rare tumors. The main objective of the study is to standardize care models and pathways for patients with rare brain tumors, using Artificial Intelligence (AI) and Machine Learning (ML) techniques to identify specific predictors of postoperative outcomes.

The study includes both retrospective and prospective phases, with the collection of clinical, cognitive, and psychological data at various time points. Patients will undergo an early neuro-cognitive rehabilitation program using the RehaCom software, which will be conducted at home. The goal is to improve the quality of life and care for patients through a multidisciplinary and innovative approach.

Detailed Description

Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients.

This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (\<6 cases per 100,000 people/year).

The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery).

Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home.

The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors.

The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation.

The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-27
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults (age ≥18 years)
• Both sexes
• Patients with rare brain tumors (incidence <6 cases per 100,000 people/year)
• Candidates for craniotomy for rare brain tumors
• Native Italian speakers for cognitive and psychological evaluation and neuro-cognitive rehabilitation

Exclusion Criteria

• Patients undergoing stereotactic/frameless biopsy
• Patients with psychiatric disorders or on psychotropic medications
• Patients with known cognitive decline (not due to the lesion)
• Patients admitted on the same day as the surgery
• Patients with severe impairments referred to rehabilitation centers
• Patients without a Windows PC or laptop with Internet connection for neuro-cognitive rehabilitation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Symptoms/Signs Onset	Pre-operative	Monitoring of headache, seizures, and neurological deficits pre- and post-operatively.; Unit of Measure: Number of patients with specific symptoms.
Karnofsky Performance Status (KPS)	Pre-operative, discharge, follow-up at 3, 6, and 12 months.	Assessment of functional capacity on a scale from 0 to 100, where 100 indicates no symptoms and full activity, and 0 indicates death.
Neurology Assessment in Neuro-Oncology (NANO)	Pre-operative, discharge, follow-up at 3, 6, and 12 months.	Evaluation of neurological function using the NANO scale, which assesses nine clinically relevant domains: gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior. Each domain is scored from 0 to 4, with higher scores indicating greater impairment.
Modified Rankin Scale (mRS)	Pre-operative, discharge, follow-up at 3, 6, and 12 months	Measurement of disability or dependence in daily activities on a scale from 0 to 6, where 0 indicates no symptoms and 6 indicates death.
American Society of Anesthesiologists (ASA)	Pre-operative	Assessment of the patient's physical status before surgery using the ASA classification system. This system categorizes patients based on their overall health and the presence of systemic diseases. ASA classification score from I to VI, with higher scores indicating greater severity of systemic disease and higher perioperative risk.
Charlson Comorbidity Index (CCI)	Pre-operative	The CCI evaluates comorbid conditions to predict ten-year mortality. It includes 17 categories of comorbidities, such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, hemiplegia, chronic kidney disease, solid tumor, leukemia, lymphoma, and AIDS. Each condition is assigned a score based on its associated risk of mortality. The total score is the sum of the individual scores for each condition, with higher scores indicating a greater number of comorbid conditions and higher predicted mortality.
Magnetic Resonance Imaging (MRI)	Pre-operative, discharge, follow-up at 3, 6, and 12 months.	Measurement of tumor size (in cm or mm), location (e.g., frontal lobe, temporal lobe), and side (right, left, bilateral).
Eloquent Area Involvement	Intra-operative	Assessment of whether the tumor involves eloquent brain areas (motor, sensory, language, visual; dominant hemisphere). Unit of Measure: Yes/No.
Cranial Nerve Manipulation	Intra-operative	Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No
Vascular Manipulation	Intra-operative	Assessment of vascular involvement during surgery (specify vessels: ICA, ACA, MCA, Acom, PcomA, anterior choroidal, ophthalmic, vertebral, basilar, PICA, AICA, SCA, posterior cerebral; superior sagittal sinus, transverse, sigmoid, straight, internal cerebral veins, vein of Galen, Labbe, Trolard. unit of Measure: Yes/No
Extent of Resection	Post-operative immediate	Measurement of the extent of tumor resection (total 100% (GTR), subtotal 90-100% (STR), partial \<90% (PR), open biopsy, needle biopsy
Edema	Pre-operative	Evaluation of the presence and extent of edema (no, perilesional, diffuse), Unit of Measure: Yes/No, extent in cm or mm
Deep Location	Pre-operative	Assessment of whether the tumor is located in deep brain structures (basal ganglia, brainstem, pineal, thalamus, hypothalamus, unit of Measure: Yes/No
Histology and Molecular Data	Post-operative	Histological classification according to WHO 2021, integrated with molecular data
Preoperative Neurological Examination (EON)	Pre-operative	Description of deficits (none; motor; sensory; cognitive; language; cranial nerves; intracranial hypertension; epilepsy; hormonal/hypothalamic disturbances; optic pathways; cerebellar, unit of Measure: Type of deficit
Tumor Side	during surgery	Side of the tumor (right; left; bilateral; median).
Tumor Location	pre-procedure	Location of the tumor (frontal, Rolandic, Broca, insular, temporal, parietal, occipital, intraventricular (lateral only), third ventricle, sella, sella+suprasellar/parasellar, clivus, optic+optic pathways, orbit, petroclival, cavernous sinus, planum/olfactory grooves, clinoid, falx, cerebellar, cerebellopontine angle, medulla, pons, midbrain, fourth ventricle, foramen magnum, pineal).
Cranial Nerve Status	pre-procedure	Status of cranial nerves I-XII (normal; deficit), House-Brackmann scale for cranial nerve VII (1-5), hearing status for cranial nerve VIII (useful hearing; non-useful hearing), status of cranial nerves IX-X (normal; deficit; tracheostomy; PEG).
Cognitive Data Collection: Phonemic Verbal Fluency	Pre-operative, follow-up at 3 and 12 months.	Assessment of verbal fluency by asking patients to generate as many words as possible beginning with a specific letter within a set time limit.; Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Cognitive Data Collection: Semantic Verbal Fluency	Pre-operative, follow-up at 3 and 12 months.	Assessment of verbal fluency by asking patients to generate as many words as possible within a specific category (e.g., animals) within a set time limit.; Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Cognitive Data Collection:Token Test	Pre-operative, follow-up at 3 and 12 months.	Assessment of language comprehension by asking patients to follow verbal instructions involving tokens of different shapes, sizes, and colors.; Unit of Measure: Higher scores indicate better language comprehension.
Cognitive Data Collection: Digit Span Forward and Backward	Pre-operative, follow-up at 3 and 12 months.	Assessment of working memory by asking patients to repeat a sequence of numbers in the same order (forward) and in reverse order (backward).; Unit of Measure: Number of digits correctly recalled. Higher scores indicate better working memory.
Cognitive Data Collection: Rey 15-Word List	Pre-operative, follow-up at 3 and 12 months.	Assessment of verbal memory by asking patients to recall a list of 15 words immediately after presentation and after a delay.; Unit of Measure: Number of words correctly recalled. Higher scores indicate better verbal memory.
Cognitive Data Collection: Rey Figure Reproduction	Pre-operative, follow-up at 3 and 12 months.	Assessment of visuospatial memory by asking patients to reproduce a complex figure from memory.; Unit of Measure: Score on the Rey Figure Reproduction. Higher scores indicate better visuospatial memory.
Cognitive Data Collection: Modified Taylor Complex Figure	Pre-operative, follow-up at 3 and 12 months.	Assessment of visuospatial construction and memory by asking patients to copy and then reproduce a complex figure from memory.; Unit of Measure: Score on the Modified Taylor Complex Figure. Higher scores indicate better visuospatial construction and memory.
Cognitive Data Collection:Trail Making Test	Pre-operative, follow-up at 3 and 12 months.	Assessment of attention and task-switching by asking patients to connect a sequence of numbered and lettered circles as quickly as possible.; Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Cognitive Data Collection: Stroop Test	Pre-operative, follow-up at 3 and 12 months.	Assessment of cognitive flexibility and processing speed by asking patients to name the color of the ink in which a word is printed, which may differ from the word itself (e.g., the word "red" printed in blue ink).; Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Cognitive Data Collection: Mini-Mental State Examination (MMSE)	Pre-operative, discharge, follow-up at 3 and 12 months.	Assessment of general cognitive function, including orientation, registration, attention and calculation, recall, and language.; Unit of Measure: Score on the MMSE (0-30). Higher scores indicate better cognitive function.
Cognitive Data Collection: Frontal Assessment Battery	Pre-operative, follow-up at 3 and 12 months.	Assessment of executive functions, including conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.; Unit of Measure: Score on the FAB (0-18). Higher scores indicate better executive function.
Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0)	Pre-operative, follow-up at 3, 6, 9 and 12 months.	Assessment of disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). This tool evaluates six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100, with higher scores indicating greater disability.
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Pre-operative, follow-up at 3, 6, 9 and 12 months.	Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This 30-item questionnaire measures various aspects of quality of life in cancer patients, including physical, role, cognitive, emotional, and social functioning, as well as symptoms and global health status. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate worse symptoms
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasms 20 (EORTC QLQ-BN20)	Pre-operative, follow-up at 3, 6, 9 and 12 months.	Assessment of quality of life specific to brain tumor patients using the EORTC QLQ-BN20. This module evaluates symptoms and issues relevant to brain tumor patients, such as future uncertainty, visual disorders, motor dysfunction, and communication deficits. Higher scores indicate worse symptoms or issues.
Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)	Pre-operative, follow-up at 3, 6,9 and 12 months.	Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). This 14-item tool produces two subscales: HADS-A (anxiety) and HADS-D (depression). Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety or depression.

Trial Locations

Locations (2)

Fondazione IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milano, PA, Italy

ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila; 🇮🇹 L'Aquila, Italy