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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Parkinson Disease; Alzheimer Disease; Malignant Brain Tumor
• Intervention / Treatment: Device: PET/MR

Detailed Description

Calculation of sample size:

Conduct research using artificial intelligence on the exact diagnosis and target localization of PET/MR for four different diseases: Alzheimer's disease, Parkinson's disease, epilepsy, and malignant brain tumors. Consequently, the following must be calculated independently from the viewpoints of statistics and picture post-processing modeling, whichever is greater:

Referring to the previous studies and the expected sensitivity of this study, the sample sizes were 519, 437, 509, and 509. Considering the 10% loss, data was adjusted to 570, 480, 560 and 560 To meet the requirements, the research will involve 550 cases of epilepsy, 550 cases of Parkinson's disease, 550 cases of Alzheimer's disease, 550 cases of malignant brain tumors, and 100 cases of healthy persons.

Data Entry:

The researchers will promptly, completely, accurately, and clearly load the data into the case report form, according to the original observation records of the subjects. The questionnaire, reviewed and signed by the supervisor, should be sent to the clinical research data administrator in time.

The input is performed using the corresponding electronic database system, involving two people and two machines. Afterward, the database is compared twice. If any issues are discovered during this process, the inspectors are promptly notified, and the researchers are required to provide answers. The exchange of various questions and answers between them should be documented in the form of a questionnaire and kept for future reference.

Main Evaluation Indicators:

Cases of major brain diseases (Alzheimer's disease, Parkinson's disease, epilepsy, and brain tumors) scanned using domestic and imported PET/MR equipment in a specific year were collected. Clinical diagnosis serves as the gold standard for Alzheimer's disease, Parkinson's disease, and epilepsy cases, while surgical pathology or biopsy results are used as the gold standard for brain tumor cases. The evaluation focuses on the sensitivity (true positive rate) and specificity of PET/MR imaging diagnosis, as well as the accuracy (true negative rate) and precision (rate of correct identification).

• Study Type: Observational
• Enrollment (Estimated): 2300

Contacts and Locations

• Study Contact: Name: Jie Lu, Phd; Phone Number: +86 13309824318; Email: imaginglu@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital
      • Contact: Jie Lu, Phd; Phone Number: +86 13309824318

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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

Description

Inclusion Criteria:

1. 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.
2. Patients admitted to our hospital for inpatient treatment.

Exclusion Criteria:

1. 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.
2. Patients with persistent seizures or status epilepticus that cannot be controlled by medication, resulting in an inability to cooperate with the examination.
3. patients with poorly controlled blood sugar and ineffective medication intervention.
4. Patients with absolute contraindications for PET/MR examination.
5. Karnofsky Performance Score (KPS) <60.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alzheimer's Disease (AD); The study will collect PET/MR multimodal imaging data, including brain structure, cerebral perfusion, brain function, glucose metabolism, and Aβ deposition, from 100 healthy volunteers, 250 patients with MCI, and 300 patients with AD. Abnormal changes in imaging biomarkers will be analyzed quantitatively, specifically for AD, to determine the specific quantitative threshold for diagnosing AD using 18F-FDG PET and 18F-AV-45 PET and establish imaging biomarkers for early diagnosis of AD. Longitudinal follow-up will be conducted to analyze multimodal imaging data dynamically and discover imaging biomarkers for early prediction of subjective cognitive decline (SCD), MCI, and AD progression.	Device: PET/MR; PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases
Parkinson's Disease (PD); The study aims to collect PET/MR multimodal imaging data from 250 patients with rapid eye movement sleep behavior disorder (RBD) and 300 patients with Parkinson's disease (PD) across multiple centers. The imaging data will include brain structure, brain iron deposition, brain function, glucose metabolism, and vesicular monoamine transporter levels, among other imaging biomarkers. Abnormal changes in these imaging biomarkers will be analyzed quantitatively to determine the specific quantitative threshold for diagnosing PD using 18F-FDG PET and 18F-AV-133 PET and establish imaging biomarkers for early diagnosis of PD. Longitudinal follow-up will be conducted to dynamically analyze the multimodal imaging data and discover imaging biomarkers for early prediction of RBD and PD progression.	Device: PET/MR; PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases
Epilepsy(EP); The study aims to collect PET/MR multimodal imaging data from 550 patients with epilepsy across multiple centers. The imaging data will include brain structure, brain function, glucose metabolism, and microglial cell activity, among other imaging biomarkers, to identify abnormal changes characteristic of epilepsy. Key features will be quantitatively analyzed to determine the specific quantitative threshold for diagnosing epilepsy using 18F-FDG PET and 18F-DPA714 PET and establish imaging biomarkers for epilepsy diagnosis. Using pathological results as the gold standard, the analysis of imaging data from lesions and surrounding brain tissue aims to discover imaging biomarkers that differentiate lesions from normal brain tissue and establish imaging markers for precise localization of epilepsy lesions.	Device: PET/MR; PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases
Malignant Brain Tumors(MBT); A total of 550 patients with malignant brain tumors (gliomas, metastatic tumors, and lymphomas) were collected from multiple centers for PET/MR multimodal imaging of brain structure, brain function, glucose metabolism, and amino acid metabolism, analyzing the characteristic abnormal changes in imaging markers. Using pathological results as the gold standard, specific quantitative threshold values for diagnosing different pathological types of malignant brain tumors using 18F-FDG PET and 18F-FET PET were determined, establishing imaging biomarkers for the diagnosis of malignant brain tumor pathology. Analysis of imaging data of the tumor and surrounding brain tissue revealed imaging markers for distinguishing tumors from surrounding normal brain tissue, enabling precise localization of malignant brain tumors.	Device: PET/MR; PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUVr measurement in lesions by 18F-FDG PET images	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; 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.	3，6，12 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMSE score for AD	Outcome evaluation of PET/MR diagnosed AD patients with MMSE and MOCA scores after treatment	3，6，12 month
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.	12 months
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	3，6，12 month
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.	3，6，12 month

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Sun Yat-sen University; Shanghai Zhongshan Hospital; Peking University Cancer Hospital & Institute; Shanghai Jiao Tong University School of Medicine; Henan Provincial People's Hospital; Wuhan TongJi Hospital; Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences; Shanghai East Hospital of Tongji University
• Investigators: Principal Investigator: Jie Lu, Phd, Xuanwu Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Dementia; Tauopathies; Parkinson Disease; Nervous System Diseases; Alzheimer Disease; Brain Neoplasms
• Other Study ID Numbers: Xuanwu[2023]44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study does not disclose research data to the public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No