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

Parkinson Disease Clinical Trial

— CAMIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092125
• Other study ID #: Xuanwu[2023]44
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Jie Lu, Phd
• Phone: +86 13309824318
• Email: imaginglu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Neoplasms
• Epilepsy
• Malignant Brain Tumor
• Nervous System Diseases
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu hospital	Beijing	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Henan Provincial People's Hospital, Peking University Cancer Hospital & Institute, Shanghai East Hospital of Tongji University, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Sun Yat-sen University, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MMSE score for AD	Outcome evaluation of PET/MR diagnosed AD patients with MMSE and MOCA scores after treatment	3,6,12 month
Other	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
Other	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
Other	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
Primary	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