Skip to content

A single center, non inferiority, prospective clinical study on the accuracy of 99mTc FAPI SPECT/CT diagnosis of fracture related infections

A single center, non inferiority, prospective clinical study on the accuracy of 99mTc FAPI SPECT/CT diagnosis of fracture related infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096464
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection related to sexual fractures

Interventions

Gold Standard:The gold standard is the pathological examination of surgical tissue specimens: intraoperative materials are taken for pathological examination, conventional HE staining light microscopi
Index test:The enrolled patients with suspected infection associated with long bone fracture (FRI) of the limbs underwent 99mTc-FAPI SPECT/CT and 18F-FDG-PET/CT within 1 week before surgery, respectiv

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18 years. 2. History of open fracture or open/closed fracture internal fixation surgery on the long bones of the limbs. 3. Clinically suspected chronic fracture-related infection and undergoing surgery in our hospital. According to the expert consensus published at home and abroad, the criteria for suspicion of fracture-related infection include: Meet at least one clinical manifestation criterion: progressive pain, wound hematoma, exudation, etc. in a localized new-onset non-weight-bearing state, or local sinus tracts, pus, poor wound healing, etc. Meets at least one imaging criterion (CT or MRI): osteolysis, loosening of internal fixation, dead bone formation, nonunion, non-fracture site, or healed fracture site at the fracture end or around the implant Periosteal reaction. With or without laboratory abnormalities: serum inflammatory markers such as erythrocyte sedimentation rate, white blood cell count, and C-reactive protein are twice elevated or persistently elevated 4. Each patient has at least one infectious lesion that meets the above criteria (this study is based on lesions Subjects, i.e., the sample size is the number of lesions), if a patient has more than one lesion, each lesion is performed Imaging and pathological tests 5. Masquelet reconstruction treatment is proposed 6. Agree to perform 99mTc-FAPI SPECT/CT imaging and 18F-FDG PET/CT imaging. 7. Able to cooperate with the completion of examinations and follow-ups.

Exclusion criteria

Exclusion criteria: 1.Clinically diagnosed as acute fracture related infection. 2.Tumor patients. 3.FAP may be highly expressed in diseases such as IgG4 related diseases, rheumatoid arthritis, osteoarthritis, myocardial infarction, cirrhosis, and pulmonary fibrosis. 4.Patients with severe heart, lung, liver, and kidney dysfunction. 5.Pregnant or lactating women. 6.Patients who are unable to cooperate in completing the examination and follow-up.

Design outcomes

Primary

MeasureTime frame
Diagnostic sensitivity;Specificity;Positive predictive value;Negative predictive value;Accuracy;

Countries

China

Contacts

Public ContactHuang Dingde

The First Affiliated Hospital of Army Medical University

huangdingde@126.com+86 23 68766578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026