Primary Sjögren Syndrome
Conditions
Brief summary
Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.
Detailed description
Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.
Interventions
DRUG68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* pathological diagnosis confirmed by operation or biopsy. * Obtain written informed consent and accepted follow-up.
Exclusion criteria
* Pregnant, lactating women or having parenting plans during the study * Head and neck radiotherapy history ; * Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases. * Other situaition researchers considered it was not appropriate to participate in trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance | through study completion, an average of 1 year | evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| standardized uptake value (SUV) of lesion | through study completion, an average of 1 year] | comparing the SUVmax of different grades in salivary gland lesion, derived from 68Ga-P16-093 |
Contacts
Primary ContactZhaohui Zhu, MD
Backup ContactJialin Xiang
Outcome results
None listed