Research on the Application of 99mTc-TCR-FAPI SPECT Imaging in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test 68Ga-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.
Primary outcome measures
- The number of affected joints detected by 99mTC-TCR-FAPI SPECT [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- The correlation of 99mTc-CTR-FAPI SPECT with clinical characteristics [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07138729 · FAPI-RA · Categoty C, UBJ10707