Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors

This first-in-human study evaluates the clinical performance of [68Ga]Ga-FFD, a novel PET radiotracer for molecular imaging of malignant tumors. Healthy volunteers will undergo serial whole-body PET imaging after a single intravenous administration of [68Ga]Ga-FFD to characterize biodistribution, organ uptake, pharmacokinetics, and radiation dosimetry. Adult patients with malignant solid tumors will undergo [68Ga]Ga-FFD PET/CT and standard-of-care ^18F-FDG PET/CT imaging. Diagnostic performance, including lesion detection and patient-based diagnostic accuracy, will be compared between the two imaging modalities. Radiation dosimetry will be estimated using time-activity curves and the OLINDA/EXM software based on the MIRD methodology. Safety assessments will include adverse events, laboratory evaluations, electrocardiography, physical examinations, and vital signs.

Inclusion criteria

• 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).
• Adequate organ function.
• Willing and able to comply with all study procedures.

Exclusion criteria

• 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.
• Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.
• Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).
• Inability to undergo PET/CT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.