Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease characterized by the progressive loss of motor neurons in the cortex, brainstem, and spinal cord, leading to muscle atrophy, paralysis, and ultimately respiratory failure.
Conditions
Interventions
Gold Standard:Both sets of PET/MR images were acquired by Guangzhou Whole-Body Medical Imaging Technology Co., Ltd. and jointly reviewed by two nuclear medicine physicians with many years of diagnosti
Index test:The positron imaging probe 68Ga-1A12 is a colorless, clear liquid, sterilely packaged in vials, and manufactured and supplied by Guangzhou Atom High-Tech Isotope Pharmaceutical Co., Ltd.
Sponsors
The People's Hospital of Baiyun District Guangzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age 18–75 years, regardless of gender; 3. Patients diagnosed with amyotrophic lateral sclerosis (ALS) in accordance with the Revised El Escorial Criteria, and patients without non-neurological autoimmune diseases; 4. Two milliliters of venous blood will be collected during the screening period to detect DDR2 in blood exosomes, with a threshold value >= 32.3 ng/mL; 5. To ensure that blood biomarkers reflect the biological status during the typical onset phase, subjects must complete blood sampling within the time window defined as the "typical onset phase" below (completed before 18F-FDG and 68Ga-1A12 imaging, with preliminary test results obtained to determine eligibility for enrollment): For ALS subjects: the interval from the first report of progressive motor function impairment-related complaints (e.g., muscle weakness, muscle atrophy, fasciculation, etc.) to the planned blood sampling date must be = 2 points in the ALSFRS-R over 3 months); 6. 18F-FDG PET/MR results were used as the baseline assessment.
Exclusion criteria
Exclusion criteria: 1.Severe abnormalities of cardiopulmonary, hepatic, and renal functions; 2.Women who are in the preconception period, pregnant, or lactating; 3.Subjects unable to lie supine for half an hour; 4.Patients with claustrophobia or other psychiatric disorders; 5.Subjects who refuse to participate in this clinical study; 6.Patients positive for GFAP antibodies in serum or cerebrospinal fluid; 7.Subjects deemed unsuitable to participate in this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive signals of 68Ga-1A12 at specific locations;The sensitivity and specificity, as well as the diagnostic reliability, of the positron imaging agent 68Ga-1A12, a molecular probe targeting discoidin domain receptor 2 (DDR2), for the diagnosis of amyotrophic lateral sclerosis (ALS).;The accuracy of the positron imaging agent 68Ga-1A12, a molecular probe targeting discoidin domain receptor 2 (DDR2), in monitoring the treatment response in amyotrophic lateral sclerosis (ALS).; | — |
Countries
China
Contacts
Public ContactXin Jinge
The People's Hospital of Baiyun District Guangzhou
Outcome results
None listed