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The Clinical Study on the Application of the Small-Molecule Imaging Probe 18F-TSPF PET/CT in the Diagnosis and Therapeutic Monitoring of Non-Small Cell Lung Cancer.

The Clinical Study on the Application of the Small-Molecule Imaging Probe 18F-TSPF PET/CT in the Diagnosis and Therapeutic Monitoring of Non-Small Cell Lung Cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107668
Enrollment
Unknown
Registered
2025-08-15
Start date
2025-08-18
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Non-small cell lung cancer

Interventions

18F-TSPF:18F-TSPF

Sponsors

The Affiliated Hospital of Guilin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily participates in the clinical study; fully understands and is informed about the study, and personally signs the Informed Consent Form (ICF); willing and able to comply with all study procedures. 2. Aged >= 18 years and = 1.5 x 10^9/L; white blood cell count (WBC) >= 4.0 x 10^9/L; platelet count (PLT) >= 100 x 10^9/L; hemoglobin (Hb) >= 90 g/L; total bilirubin (TBIL) = 30 g/L; international normalized ratio (INR) 1.5 x ULN, creatinine clearance must be >= 50 ml/min (calculated by Cockcroft-Gault formula).

Exclusion criteria

Exclusion criteria: 1. Patients who are preparing for or have previously undergone organ or bone marrow transplantation. 2. Patients with pleural effusion, pericardial effusion, or ascites requiring clinical intervention. 3. Patients known to have or found during screening to have active central nervous system (CNS) metastases and/or carcinomatous meningitis are excluded. However, the following subjects are allowed to enroll: 1) Asymptomatic brain metastases patients (i.e., no progressive CNS symptoms caused by brain metastases, no need for corticosteroids, and lesion size = 450 ms for males and >= 470 ms for females, calculated by Fridericia’s formula) within six months prior to the first imaging. 6. Heart failure classified as NYHA class III–IV or echocardiographic findings showing left ventricular ejection fraction (LVEF) 1.5 mmol/L, or total calcium > 12 mg/dL, or corrected serum calcium above the upper limit of normal [ULN]). 8. Subjects with CTCAE peripheral neuropathy of grade >= 2. 9. Infection with human syphilis or human immunodeficiency virus (HIV). 10. Patients with active pulmonary tuberculosis. 11. Patients with hepatitis B virus infection (positive HBsAg or HBcAb and detectable HBV-DNA) or hepatitis C virus infection (positive HCV antibody and detectable HCV-RNA). Subjects with co-infection of hepatitis B and hepatitis C (positive HBsAg or HBcAb and positive HCV antibody) are also included. 12. Subjects with known active or suspected autoimmune diseases. However, subjects with stable conditions not requiring systemic immunosuppressive therapy are allowed to enroll. 13. Known history of allergy to contrast agents. 14. Pregnant or breastfeeding women. 15. Known history of psychiatric medication abuse or substance abuse. 16. Presence of contraindications to relevant biopsy procedures. 17. In the judgment of the investigator, the subject has other conditions that make them unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
SUVmax;

Countries

China

Contacts

Public ContactFu Wei

The Affiliated Hospital of Guilin Medical University

13977385850@126.com+86 139 7738 5850

Outcome results

None listed

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