Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT07138729
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Luo Yaping
Other
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