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

NCT07138729 | Recruiting

• 2 other identifiers: FAPI-RACategoty C, UBJ10707
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid arthritis; 68Ga-FAPI PET / CT; 99mTc-CTR-FAPI SPECT

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• The correlation of 99mTc-CTR-FAPI SPECT with clinical characteristics

  through study completion, an average of 1 year

Study Arms (1)

68Ga-FAPI PET/CT& 99mTc-CTR-FAPI SPECT

EXPERIMENTAL

All enrolled patients will undergo one 99mTc-CTR-FAPI SPECT scan and one 68Ga-FAPI PET/CT scan within a 1-week interval.

Diagnostic Test: 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT

Interventions

68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT DIAGNOSTIC_TEST

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.

68Ga-FAPI PET/CT& 99mTc-CTR-FAPI SPECT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luo Yaping: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yaping LUO

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo, MD

CONTACT

86-010-69154716; luoyaping@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor (M.D.), Chief Physician, Professor, Assistant Director

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 24, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)