Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorXuanwu Hospital, Beijing

About this trial

The goal of this clinical trial is to learn about the application of domestic PET/MR in major brain diseases. The main questions it aims to answer are:

* Overcome the bottleneck of early accurate diagnosis and treatment in major brain diseases clinical practice. * Promote the clinical application of domestic PET/MR, enhance international competitiveness. Participants will have a PET/MR scan of the brain.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with mild cognitive impairment (MCI) or Alzheimer's disease (AD), rapid eye movement sleep behavior disorder (RBD) or Parkinson's disease (PD), epilepsy, malignant brain tumors based on clinical guidelines.

Patients admitted to our hospital for inpatient treatment.

Disqualifiers

Patients who have undergone non-invasive/minimally invasive treatments such as radiotherapy or chemotherapy within the past three weeks. And Patients who have taken Alzheimer's disease-related and Parkinson's disease-related treatment drugs within the past month.

Patients with persistent seizures or status epilepticus that cannot be controlled by medication, resulting in an inability to cooperate with the examination.

patients with poorly controlled blood sugar and ineffective medication intervention.

Patients with absolute contraindications for PET/MR examination.

Trial population

1. Patients diagnosed with mild cognitive impairment (MCI) or Alzheimer's disease (AD) based on clinical guidelines. 2. Patients diagnosed with rapid eye movement sleep behavior disorder (RBD) or Parkinson's disease (PD) based on clinical guidelines. 3. Patients in accordance with the Chinese guidelines for clinical diagnosis and treatment of epilepsy 4. Patients suspected of malignant brain tumors based on the 2022 Chinese Clinical Guidelines for Gliomas and the 2021 edition of the NCCN Clinical Practice Guidelines in Oncology for Brain Tumors

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PET/MR

    Device

    PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases

Treatment groups

2,300 Participants
are divided into 4 treatment groups
Group A: Alzheimer's Disease (AD)1 intervention
Group B: Parkinson's Disease (PD)1 intervention
Group C: Epilepsy(EP)1 intervention
Group D: Malignant Brain Tumors(MBT)1 intervention

Trial outcomes

Primary outcomes

1

SUVr measurement in lesions by 18F-FDG PET images

1. For AD and PD outcome assessment uses 18F-FDG-PET images for qualitative and quantitative follow-up. The SUVr improvement of 20% or more from baseline is considered a good outcome.An increase in SUVr of less than 20% from the baseline period is considered steady state.Decreased SUVr from baseline was considered a poor outcome 2. For EP and MBT outcome assessment uses 18F-FDG-PET images for qualitative and quantitative follow-up. A reduction in SUVr of more than 70% from baseline period measurements was considered a good outcome. A 50-70% reduction in SUVr from baseline period measurements was considered a stable outcome.A decrease of less than 50% or an increase in SUVr from baseline period measurements was considered a poor outcome.

Time frame
3,6,12 month

Secondary outcomes

Other outcomes

1

MMSE score for AD

Outcome evaluation of PET/MR diagnosed AD patients with MMSE and MOCA scores after treatment

Time frame
3,6,12 month
2

UPDRS evaluation for PD

Using UPDRS for Post-Treatment Assessment in PET/MR Diagnosed PD: UPDRS scores post PET/MR-diagnosed PD guide prognosis categorization: good, stable, poor outcomes. Ranges vary slightly but generally are: * Good Prognosis: Significant symptom improvement, UPDRS scores 0-30. * Stable Prognosis: Minimal changes, UPDRS scores 31-60. * Poor Prognosis: Limited improvement or worsening, UPDRS scores 61+. UPDRS scores assess treatment efficacy, inform care decisions after PET/MR-based PD diagnosis.

Time frame
12 months
3

Engle level for EP

Patients with PET/MR diagnosis and localized epileptic foci were evaluated for efficacy by applying engle grading at 3, 6, and 12 months of treatment Disease-specific clinical score follow-up indicators:Engle classification score at 6 months, 1 year, and 2 years post-treatment follow-up, Engle Ia for good prognosis, Engle Ib-IV for poor prognosis

Time frame
3,6,12 month
4

RANO score for MBT

Patient outcomes based on RANO scores were evaluated at 3, 6, and 12 months post-treatment for those with malignant brain tumors confirmed by PET/MR diagnosis and postoperative pathology. After treatment, RANO criteria guide follow-ups for brain tumor patients. These criteria standardize response evaluation, aiding treatment assessment and management decisions. Responses fall into categories: * Complete Response (CR): No measurable tumor remains on scans; tumor disappearance indicates successful treatment response. * Partial Response (PR): Tumor size reduces; significant decrease in burden suggests positive treatment impact. * Stable Disease (SD): Minimal tumor size change; fluctuations not meeting progression or response criteria. * Progressive Disease (PD): Tumor increases or new lesions appear; growth or spread despite treatment. Responses are assessed using MRI and clinical factors, considering tumor size and patient condition.

Time frame
3,6,12 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Wuhan TongJi Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

Sun Yat-sen University

Collaborator

Shanghai East Hospital of Tongji University

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Collaborator

Shanghai Jiao Tong University School of Medicine

Collaborator