An exploratory study of FAPI PET/CT in evaluation of disease activity and prognosis in anti-MDA5+ DM-related ILD

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200064617

Enrollment

Unknown

Registered

2022-10-13

Start date

2022-10-10

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Anti-MDA5+ DM-related ILD

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with anti-MDA5 DM ILD disease course within 6 months according to the Classification and Diagnostic Criteria for IIMs released by the European Center for Neuromuscular Diseases (ENMC) and the American Myopathy Research Collaborative Group in 2018 (239th); 2. Over 18 years old; 3. Women of reproductive age agreed to use effective contraception during the study; 4. Patients or family members agreed to participate in the clinical study and signed informed consent;

Exclusion criteria

Exclusion criteria: 1. Patients with other connective tissue diseases or tumors; 2. Pregnant and lactating women; 3. A history of surgery or trauma that significantly affected metabolic distribution and anatomical structure; 4. Patients with invasive mechanical ventilation; 5. Unable to complete PET-CT examination; 6. Those that the investigator considers inappropriate to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
All-cause mortality at month 6;All-cause mortality at month 12;	—

Secondary

Measure	Time frame
FVC at month 6;HRCT at month 6;FVC at month 9;HRCT at month 9;FVC at month 12;HRCT at month 12;	—

Countries

China

Contacts

Public ContactJia Li

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicnie

leejiasjtu@163.com+86 13916321659

Outcome results