Research on the Application of 99mTc-TCR-FAPI SPECT Imaging in Rheumatoid Arthritis
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLuo Yaping
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-75 years old;
Meet the classification criteria for rheumatoid arthritis of the American College of Rheumatology/European Union for Rheumatology in 2010;
The highest disease activity in clinical practice (CDAI or SDAI score
Disqualifiers
Patients with other autoimmune diseases;
Patients with concurrent tumors;
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;
Active infection
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT
Diagnostic testFor 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 68Ga-FAPI PET/CT& 99mTc-CTR-FAPI SPECTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of affected joints detected by 99mTC-TCR-FAPI SPECT
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 yearSecondary outcomes
1
The correlation of 99mTc-CTR-FAPI SPECT with clinical characteristics
(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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Luo Yaping
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Peking Union Medical College Hospital
Collaborator
Source ClinicalTrials.gov