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Trial Title:
Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease
NCT ID:
NCT06092125
Condition:
Alzheimer Disease
Parkinson Disease
Epilepsy
Malignant Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Parkinson Disease
Alzheimer Disease
Nervous System Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
PET/MR
Description:
PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types
of diseases
Arm group label:
Alzheimer's Disease (AD)
Arm group label:
Epilepsy(EP)
Arm group label:
Malignant Brain Tumors(MBT)
Arm group label:
Parkinson's Disease (PD)
Summary:
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.
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).
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Xuanwu hospital
Address:
City:
Beijing
Zip:
100053
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Lu, Phd
Phone:
+86 13309824318
Start date:
February 1, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Xuanwu Hospital, Beijing
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan TongJi Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Shanghai East Hospital of Tongji University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Agency class:
Other
Collaborator:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Xuanwu Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092125
