Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
NCT ID: NCT07301801
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2025-06-12
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-FL-031 Group
This is one diagnostic study. Firstly, oncologists screen patients with malignant tumors such as small cell lung cancer, breast cancer, head and neck cancer and so on, who are clinically suspected or confirmed.
Secondly, investigators will talk to patients who meet the inclusion criteria, explain the study purpose and process; the patients are required to sign informed consent forms, and receive the 18F-FDG and 68Ga-FL-031PET scanning respectively in outpatient or inpatient periods.
Thirdly, general information, clinical data, blood routine, urine routine, liver and kidney function and other biochemical indicators, electrocardiogram, radionuclide imaging results and other imaging data of the patients participating in the study were collected and compared with histopathology to evaluate the value of both imaging in the diagnosis of the above mentioned malignant tumors.
Injection of 68Ga-FL-031
Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points
Injection of 18F-FDG
Patients will be injected with 18F-FDG and PET imaging was performed
Interventions
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Injection of 68Ga-FL-031
Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points
Injection of 18F-FDG
Patients will be injected with 18F-FDG and PET imaging was performed
Eligibility Criteria
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Inclusion Criteria
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
2. The patient is unable to cooperate with the implementation of the whole process research
3. The patient has been diagnosed with acute systemic diseases and electrolyte disorders
4. Pregnant women or lactating women, etc
5. 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.
18 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Xiaoli Lan
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoli Lan, Professor
Role: primary
Other Identifiers
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XLan-0603
Identifier Type: -
Identifier Source: org_study_id