Xuanwu hospital
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
NCT Number: NCT06092125
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases
Time frame: 3,6,12 month
Time frame: 3,6,12 month
Outcome evaluation of PET/MR diagnosed AD patients with MMSE and MOCA scores after treatment
Time frame: 12 months
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:
UPDRS scores assess treatment efficacy, inform care decisions after PET/MR-based PD diagnosis.
Time frame: 3,6,12 month
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
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:
Responses are assessed using MRI and clinical factors, considering tumor size and patient condition.
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
Acronym: CAMIND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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