Research on the Application of 99mTc-TCR-FAPI SPECT Imaging in Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis (RA)

• Registration Number: NCT07138729
• Lead Sponsor: Luo Yaping

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.

Study Timeline

• Study First Submitted: 2025-05-07
• Study Start: 2025-05-10
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Primary Completion: 2027-12-01
• Study Completion: 2028-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China