[18F]NIDF PET Imaging in Tau-related Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorTianjin Medical University
About this trial
In the field of diagnosing brain neurodegenerative diseases, it is now a well-established practice to inject positron-emitting tracers into the human body. These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own tau imaging agents.
This clinical research project aims to visualize abnormal tau pathology in the living human brain using \[18F\]NIDF PET imaging. \[18F\]NIDF is a 2-arene-azaindole-based tracer that offers stronger binding affinity to tau neurofibrillary tangles and reduced non-specific/off-target binding compared to existing tau-PET imaging agents. The study primarily focuses on evaluating the safety and diagnostic efficacy of \[18F\]NIDF PET imaging in human subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 18 and 90 years old;
No gender limitation;
Clinical diagnositic rerults supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases;
Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes;
Disqualifiers
Has allergy to [18F]NIDF or any of its excipients;
Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
Unwilling or unable to undergo PET scans tracer injections;
Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
Trial population
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Healthy participants
Group B: Patients with cognitive impairment
Trial outcomes
Primary outcomes
1
Safety Assessment
The incidence of adverse events assessed by the investigator as related to the \[18F\]NIDF injection. Systematically collect and assess all adverse events within 7 days post-injection through physical examinations, vital signs monitoring, clinical laboratory tests (complete blood count, hepatic and renal function). All events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time frame
From time of injection up to 7 days post-injection2
The Biodistribution of [18F]NIDF in subjects
Semi-quantitatively evaluate the tracer's uptake in the interest brain regions, like cortical cortex, hippocampus and cerebellum, by measuring the Standard Uptake Value (SUV) or % inject dose per volum (%ID/cc).
Time frame
At the time of the single [18F]FT8 PET/CT scan (Day 1)Secondary outcomes
1
Diagnostic Performance
Diagnostic performance including sensitivity, specificity, accuracy. Quantification of \[18F\]NIDF uptake in different brain regions (e.g., amygdala, temporal lobe, hippcampus) using the Standardized Uptake Value (SUV). This measurement will be performed on the PET/CT scans acquired at a specified time. The outcome will be reported as the SUV in both two groups.
Time frame
From enrollment to the end of PET/CT sacns at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tianjin Medical University
Lead sponsor
Tianjin Medical University General Hospital
Collaborator
Source ClinicalTrials.gov