Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-FFD.
- Who it may be relevant to
- Registry conditions: Solid Tumor Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
Interventions
- Drug [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.
Primary outcome measures
- Visual and standardized uptake values assessment of lesions and biodistribution [Time frame: one month]
Secondary outcome measures (2)
- Incidence of Treatment-Emergent Adverse Events [Time frame: From administration of [68Ga]Ga-FFD through 7 days after PET imaging.]
- Biodistribution of [68Ga]Ga-FFD [Time frame: Approximately 0.5 hours and 2 hours after tracer administration.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Union Hospital, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07708103 · Xlan-20260332