This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \[68Ga\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \[68Ga\]Ga-FFD PET imaging in addition to standard-of-care \^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.
Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.
Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.
ECOG performance status of 0-1 for patients.
Clinical indication for ^18F-FDG PET/CT imaging (patient cohort only).
Pregnant or breastfeeding women.
Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.
Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.
Active uncontrolled infection requiring systemic treatment.
Single group
[68Ga]Ga-FFD
DrugFor Cancer patients, \[68Ga\]Ga-FFD is a gallium-68-labeled PET radiotracer administered as a single intravenous injection at approximately 185 MBq (5 mCi ±10%) for molecular imaging. Whole-body PET/CT imaging will be performed at approximately 0.5 and 2 hours after administration to evaluate tracer biodistribution, radiation dosimetry, safety, and diagnostic performance.
Visual and standardized uptake values assessment of lesions and biodistribution
PET images will be independently reviewed by at least two experienced nuclear medicine physicians who are blinded to each other's interpretations. Histopathological findings, when available, together with clinical and imaging follow-up, will serve as the reference standard for lesion verification. Both visual and semiquantitative analyses will be performed for each participant. Semiquantitative analysis will include measurement of the maximum and mean standardized uptake values (SUVmax and SUVmean) of tumor lesions and major normal organs at each imaging time point. Lesion detection, tracer biodistribution, tumor-to-background ratios, and image quality will also be evaluated.
Incidence of Treatment-Emergent Adverse Events
Safety will be evaluated by assessing the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), together with changes in vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms following administration of \[68Ga\]Ga-FFD.
Biodistribution of [68Ga]Ga-FFD
Percentage of injected dose (%ID), SUVmean, and residence time in major organs and tissues will be measured at each imaging time point. Time-activity curves will be generated for quantitative biodistribution analysis.
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