68Ga-FL-031 PET Imaging in Diagnosis and Staging of Various Malignant Tumors
This early phase study aims to evaluate how well 68Ga-FL-031 PET imaging can diagnose and stage various types of cancer in affected individuals.
Injection of 68Ga-FL-031
+ Injection of 18F-FDG
Neoplasms
Diagnostic Study
Summary
Study start date: June 12, 2025
Actual date on which the first participant was enrolled.This study focuses on a specific type of imaging called 68Ga-FL-031 PET and its role in diagnosing and staging various types of cancer, including small cell lung cancer, breast cancer, nasopharyngeal carcinoma, and others. The goal is to understand how well this imaging technique can identify the presence, location, and spread of cancer. This research is important as it could potentially improve the accuracy of cancer diagnosis and staging, leading to more effective treatment plans and better patient outcomes. Participants in this study are individuals with confirmed or suspected cancer who will undergo both 68Ga-FL-031 PET and 18F-FDG PET imaging. The results of these imaging tests will be compared with the final diagnostic criteria obtained from biopsy or surgical specimens. The study also aims to analyze the correlation between the uptake value of the tumor tissue in the 68Ga-FL-031 PET imaging and the expression of a specific target, SSTR2, in the tumor tissue immunohistochemical staining.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: 1. The patient or his legal representative is unable or unwilling to sign the informed consent 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location