Actively Recruiting
Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-24
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 68Ga-FL-031 PET imaging in diagnosing and staging malignant tumors, including small cell lung cancer, breast cancer, nasopharyngeal carcinoma, and others. This study aims to analyze how well 68Ga-FL-031 PET imaging detects tumor lesions, their location, nature, and spread compared to 18F-FDG PET imaging. It also examines the relationship between the uptake of 68Ga-FL-031 in tumor tissue and the expression of the SSTR2 target through immunohistochemical staining. Participants will receive injections of two imaging agents: 68Ga-FL-031 and 18F-FDG, followed by PET scans at different times during outpatient or inpatient visits. The study involves collecting clinical data, blood and urine tests, liver and kidney function tests, electrocardiograms, and various imaging results. These data will be compared with biopsy or surgical specimen histopathology to evaluate diagnostic accuracy. During the study, patients will provide general health information and undergo multiple assessments to monitor the uptake values of lesions and biodistribution over one year. Researchers will review pathological sections of tumor tissue within the same period. The study requires participants to follow the prescribed research procedures, including signing informed consent and cooperating fully throughout the process.
CONDITIONS
Brief Title
Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject or their legal representative can sign the informed consent form
- The subject agrees to follow the study procedures and cooperate throughout the study
- Adult patients aged 18 years or older, any gender
- Patients with clinical suspicion or confirmed diagnosis of small cell lung cancer, breast cancer, nasopharyngeal carcinoma, or other tumors supported by serum markers, imaging, and histopathology
- Patient is generally in good condition
- Agreement to use designated specimens for study purposes
You will not qualify if you...
- Patient or legal representative unable or unwilling to sign informed consent
- Patient unable to cooperate with study procedures
- Diagnosis of acute systemic diseases or electrolyte disorders
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator due to intolerance to SSTR2 targeted substances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several days during outpatient or inpatient periods
Participants receive injections of 18F-FDG and 68Ga-FL-031 followed by PET imaging to assess malignant tumors.
2 visits (in-person) for PET scans with each injection
Duration - 1 year
Participants' imaging results, clinical data, and pathological sections are collected and compared over one year to evaluate diagnostic value.
Periodic visits as required for data collection
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
X
Xiaoli Lan, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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