Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injection of 68Ga-FL-031, Injection of 18F-FDG.
- Who it may be relevant to
- Registry conditions: Malignant Tumors, SSTR2, PET. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Injection of 68Ga-FL-031
Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points - Drug Injection of 18F-FDG
Patients will be injected with 18F-FDG and PET imaging was performed
Primary outcome measures
- Visual and standardized uptake values assessment of lesions and biodistribution [Time frame: 1 year]
Secondary outcome measures (1)
- Pathological sections of tumour tissue [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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)
- The patient is generally in good condition
- It is mutually agreed upon by all parties involved that the designated specimen shall be utilised for the purposes of this study.
Exclusion criteria
- 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
- In the event of other circumstances being deemed by the investigator to be unsuitable for participation in the study, such patients must be excluded on the basis of their known intolerance to SSTR2 targeted substances.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Wuhan Union Hospital — Wuhan
Identifiers
NCT: NCT07301801 · XLan-0603