About this trial
The project's objective is to recruit patients with clinically confirmed or suspected small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumours for 68Ga-FL-031 PET imaging and 18F-FDG PET imaging. The histopathology of biopsy or surgical specimens was taken as the final diagnostic criteria, and the presence or absence of tumour lesions was confirmed by the aforementioned imaging. The location and nature of the lesion, and the presence or absence of metastasis, were then judged. The objective was to analyse and clarify the diagnostic efficacy of 68Ga-FL-031 PET imaging for the aforementioned malignant tumours. The objective of this study is to analyse the correlation between the 68Ga-FL-031 PET imaging tumour tissue uptake value and the tumour tissue immunohistochemical staining SSTR2 target expression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject or their legal representative is permitted to sign the informed consent form.
The subject has committed themselves to adherence to the prescribed research procedures and to cooperation in the implementation of the entire study process.
Adult patients (aged 18 years or older), irrespective of gender
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)
Disqualifiers
The patient or his legal representative is unable or unwilling to sign the informed consent
The patient is unable to cooperate with the implementation of the whole process research
The patient has been diagnosed with acute systemic diseases and electrolyte disorders
Pregnant women or lactating women, etc
Trial design
Single group
Treatments tested in this trial
Injection of 68Ga-FL-031
DrugPatients will be injected with 68Ga-FL-031and PET imaging was performed at different time points
Injection of 18F-FDG
DrugPatients will be injected with 18F-FDG and PET imaging was performed
Treatment groups
Trial outcomes
Primary outcomes
Visual and standardized uptake values assessment of lesions and biodistribution
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and normal organs will be measured and the semiquantitative analysis is conducted for each patient.
Secondary outcomes
Pathological sections of tumour tissue
The tumor tissue was taken for immunohistochemistry to verify its SSTR2 expression
Sponsors and contacts
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