Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Phase EARLY_PHASE1
Started
2026-07-30
Last updated
2026-07-16
Condition(s) studied
Solid Tumor Malignancies
Investigational drug(s) / intervention(s)
[68Ga]Ga-FFD
[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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Visual and standardized uptake values assessment of lesions and biodistribution — one month 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.
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Huazhong University of Science and Technology
Wuhan
Hubei
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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