99mTc-CTR-FAPI SPECT imaging to detect inflamed joints in rheumatoid arthritis

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

This trial will test whether 99mTc-CTR-FAPI SPECT scans can detect active joint inflammation as well as 68Ga-FAPI PET/CT in adults with moderate-to-high rheumatoid arthritis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07138729 on ClinicalTrials.gov

What this trial studies

Twenty adults with rheumatoid arthritis and moderate-to-high disease activity will undergo both 99mTc-CTR-FAPI SPECT and 68Ga-FAPI PET/CT for direct, head-to-head comparison. Scans will be read independently by two nuclear medicine physicians with ≥10 years' experience, and a joint-by-joint comparison will be made between the two imaging methods. Imaging findings will be compared with tender and swollen joint counts from physical examination and correlated with clinical disease activity scores (CDAI/SDAI). The goal is to determine if the 99mTc SPECT approach provides consistent diagnostic information while offering lower cost and radiation exposure.

Who should consider this trial

Good fit: Adults aged 18–75 who meet the 2010 ACR/EULAR RA criteria and have moderate-to-high disease activity, and who can undergo nuclear imaging without contraindications, are suitable candidates.

Not a fit: Patients who are pregnant or breastfeeding, have other autoimmune diseases, concurrent cancer, active infection, severe claustrophobia, or who have low disease activity are unlikely to benefit from this imaging comparison.

Why it matters

Potential benefit: If successful, this could offer a lower-cost, lower-radiation imaging option to monitor joint inflammation and guide long-term RA care.

How similar studies have performed: 68Ga-FAPI PET/CT has shown promise for imaging synovitis in prior reports, but using a 99mTc-labeled FAPI agent with SPECT is a newer approach with limited prior validation.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Yaping LUO — Peking Union Medical College Hospital
• Study coordinator: Yaping Luo, MD

Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, 68Ga-FAPI PET / CT, 99mTc-CTR-FAPI SPECT