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Clinical application of 68Ga-FL-031 PET in the diagnosis and staging of malignant tumors

Clinical application of 68Ga-FL-031 PET in the diagnosis and staging of malignant tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117400
Enrollment
Unknown
Registered
2026-01-23
Start date
2025-06-12
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other malignant tumors

Interventions

Gold Standard:Tumor pathology diagnosis or follow-up results, and 18F-FDG PET imaging
Index test:One hour after a single intravenous injection of 18F-FDG (approximately 185 +/- 37 MBq) via the dorsal hand vein on the first day of examination, PET imaging was performed. After an overnig

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The subject or their legal representative is permitted to sign the informed consent form. 2.The subject has committed themselves to adherence to the prescribed research procedures and to cooperation in the implementation of the entire study process. 3.Adult patients (aged 18 years or older), irrespective of gender; 4.Patients with a clinical suspicion or confirmed diagnosis of small cell lung cancer, breast cancer, nasopharyngeal carcinoma, and other tumours (for which supporting evidence is provided in the form of serum-related tumour markers, ultrasound, CT, MRI and other image data, and histopathological examination); 5.The patient is generally in good condition; 6.It is mutually agreed upon by all parties involved that the designated specimen shall be utilised for the purposes of this study.

Exclusion criteria

Exclusion criteria: 1. The patient or their legal representative is unable or unwilling to sign the informed consent form; 2. The patient is unable to cooperate with the entire study procedure; 3. Acute systemic disease or electrolyte imbalance; 4. Pregnancy or lactation; 5. Other conditions deemed unsuitable for participation in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
SUVmax of lesions on 68Ga-FL-031 and 18F-FDG PET;Tumor to background ratio (TBR);SUVmean of lesions in the descending aorta for 68Ga-FL-031 and 18F-FDG.;SUVmean of lesions in the right hepatic lobe for 68Ga-FL-031 and 18F-FDG.;

Secondary

MeasureTime frame
Expression content of SSTR2 targets in lesions;

Countries

China

Contacts

Public ContactLan Xiaoli

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

hzslxl@163.com+86 27 85726685

Outcome results

None listed

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