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Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
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.
Official title: A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-07-30
Completion Date
2027-07-30
Last Updated
2026-07-16
Healthy Volunteers
Yes
Conditions
Interventions
[68Ga]Ga-FFD
For 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.
Locations (1)
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China