Rheumatoid Arthritis (RA)NCT07138729
Research on the Application of 99mTc-TCR-FAPI SPECT Imaging in Rheumatoid Arthritis
A study testing 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT in people with Rheumatoid Arthritis (RA), run by Luo Yaping at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 28 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jiayue Li, 010-69156874
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT
- Keywords
- Rheumatoid arthritis, 68Ga-FAPI PET / CT, 99mTc-CTR-FAPI SPECT
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Yaping
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor-investigator, Luo Yaping, Peking Union Medical College Hospital
- Investigators
- Yaping LUO, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138729
- Sponsor's protocol ID
- FAPI-RA
- Other IDs
- Categoty C, UBJ10707
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of 99mTc-TCR-FAPI SPECT Imaging in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07138729
- Acronym / sponsor ID
- FAPI-RA
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid arthritis, 68Ga-FAPI PET / CT, 99mTc-CTR-FAPI SPECT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Luo YapingUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI PET/CT& 99mTc-CTR-FAPI SPECT | Experimental | Diagnostic Test: 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECTAll enrolled patients will undergo one 99mTc-CTR-FAPI SPECT scan and one 68Ga-FAPI PET/CT scan within a 1-week interval. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECTFor 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. | Diagnostic test | 68Ga-FAPI PET/CT& 99mTc-CTR-FAPI SPECT |
Primary outcome
The number of affected joints detected by 99mTC-TCR-FAPI SPECT
Time frame: 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.
1 secondary outcome
The correlation of 99mTc-CTR-FAPI SPECT with clinical characteristics
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaping LUO principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI PET/CT and 99mTc-CTR-FAPI SPECT in people with Rheumatoid Arthritis (RA), run by Luo Yaping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Luo, MD (86-010-69154716, luoyaping@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of affected joints detected by 99mTC-TCR-FAPI SPECT (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.