Alzheimer DiseaseCAMINDNCT06092125
Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease
An observational study of Alzheimer Disease and Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease, Epilepsy
- What is being tested?
- PET/MR
- Type of treatment
- Medical device
- How many people
- 2,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
- Karnofsky Performance Score (KPS) <60.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital
Beijing, Beijing Municipality, 100053
Jie Lu, Phd, +86 13309824318
About this study
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.
Read the 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).
- Conditions
- Alzheimer Disease, Parkinson Disease, Epilepsy, Malignant Brain Tumor
- Being tested
- PET/MR
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Epilepsy, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDevice
PET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET/MR | |
| 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. Receives: Device: PET/MR | |
| 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. Receives: Device: PET/MR | |
| 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. Receives: Device: PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3，6，12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Oct 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Wuhan TongJi Hospital, Henan Provincial People's Hospital, Sun Yat-sen University, Shanghai East Hospital of Tongji University, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Jie Lu, Phd, Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092125
- Sponsor's protocol ID
- Xuanwu[2023]44
- Acronym
- CAMIND
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study does not disclose research data to the public
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicantion of Multi-Tracer PET/MR Imaging in Neurological Disorders/Disease
- ClinicalTrials.gov ID
- NCT06092125
- Acronym / sponsor ID
- CAMIND / Xuanwu[2023]44
- Conditions
- Alzheimer Disease, Parkinson Disease, Epilepsy, Malignant Brain Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Wuhan TongJi Hospital, Henan Provincial People's Hospital, Sun Yat-sen University, Shanghai East Hospital of Tongji University, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease (AD) | – | Device: PET/MRThe 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. |
| Parkinson's Disease (PD) | – | Device: PET/MRThe 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. |
| Epilepsy(EP) | – | Device: PET/MRThe 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. |
| Malignant Brain Tumors(MBT) | – | Device: PET/MRA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Karnofsky Performance Score (KPS) <60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRPET/MR device is used for pre-treatment evaluation and efficacy follow-up of four types of diseases | Device | Alzheimer's Disease (AD), Epilepsy(EP), Malignant Brain Tumors(MBT), Parkinson's Disease (PD) |
Primary outcome
SUVr measurement in lesions by 18F-FDG PET images
Time frame: 3，6，12 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. This study does not disclose research data to the public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Lu, Phd principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Parkinson Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Lu, Phd (+86 13309824318, imaginglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVr measurement in lesions by 18F-FDG PET images (time frame: 3，6，12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.