Rheumatoid Arthritis (RA)
Conditions
Keywords
Rheumatoid arthritis, 68Ga-FAPI PET / CT, 99mTc-CTR-FAPI SPECT
Brief summary
This study proposes to evaluate 99mTc-CTR-FAPI SPECT imaging as a cost-effective, low-radiation, and widely accessible alternative to 68Ga-FAPI PET/CT for assessing synovial lesions in RA patients, aiming to validate its diagnostic consistency with both PET/CT and physical examinations while correlating imaging findings with clinical disease activity metrics to establish a practical tool for long-term RA monitoring.
Detailed description
This study will enroll 20 rheumatoid arthritis patients meeting the 2010 ACR/EULAR classification criteria with moderate-to-high disease activity, with all participants undergoing both 99mTc-CTR-FAPI SPECT and 68Ga-FAPI PET/CT imaging for head-to-head comparison.The imaging results of both 99mTc-CTR-FAPI SPECT and 68Ga-FAPI PET/CT were independently interpreted by two nuclear medicine physicians with ≥10 years of diagnostic experience. A joint-by-joint comparison was performed between: (1) FAPI-positive joints identified by 99mTc-CTR-FAPI SPECT versus 68Ga-FAPI PET/CT, and (2) imaging-detected joints versus tender/swollen joints confirmed by physical examination.
Interventions
DIAGNOSTIC_TEST68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT
For 68Ga-FAPI PET/CT scan，each patient was injected with 1.8-2.2 MBq/kg (0.05-0.06 mCi/kg) body weight of 68Ga-FAPI. PET/CT from skull to feet was performed 60±5 min post-injection. For 99mTc-CTR-FAPI SPECT scan:each patient was injected with 10-20mCi 99mTc-CTR-FAPI . Planar SPECT scan and SPECT/CT were performed 60±5 min post-injection.
Sponsors
Peking Union Medical College Hospital
Luo Yaping
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Masking Description
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years old; 2. Meet the classification criteria for rheumatoid arthritis of the American College of Rheumatology/European Union for Rheumatology in 2010; 3. The highest disease activity in clinical practice (CDAI or SDAI score
Exclusion criteria
1. Patients with other autoimmune diseases; 2. Patients with concurrent tumors; 3. Women who are pregnant or planning to become pregnant, women in the preconception period, pregnant and lactating women, and women with child-rearing plans during the study period; Subjects of childbearing age need to take effective contraceptive measures during the research process; 4. Active infection 5. Suffering from claustrophobia or other mental disorders, with poor compliance resulting in inability to cooperate with this researcher; (6) Situations where other researchers consider it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of affected joints detected by 99mTC-TCR-FAPI SPECT | through study completion, an average of 1 year | Consistency in detecting affected joints between 99mTc-CTR-FAPI SPECT and 68Ga-FAPI PET/CT interpreted by two nuclear medicine physicians with 10 years of diagnostic experience. The joints that were positive for RA detected by 99mTc-CTR-FAPI SPECT and 68Ga-FAPI PET/CT were compared one by one, and then compared with the joints with tenderness and swelling determined by physical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of 99mTc-CTR-FAPI SPECT with clinical characteristics | through study completion, an average of 1 year | (1) Agreement among 99mTc-CTR-FAPI SPECT, 68Ga-FAPI PET/CT, and physical examination in joint assessment; (2) Correlation between imaging findings and clinical disease activity indices. |
Countries
China
Contacts
Primary ContactYaping Luo, MD
Outcome results
None listed