Clinical trial · Interventional
Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-FFD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-FFD PET Imaging
- description
- Participants will receive a single intravenous administration of \[68Ga\]Ga-FFD followed by serial whole-body PET/CT imaging. Healthy volunteers will undergo imaging for biodistribution and radiation dosimetry evaluation, while patients with malignant solid tumors will additionally undergo standard-of-care \^18F-FDG PET/CT imaging for assessment of diagnostic performance.
- interventionNames
- Drug: [68Ga]Ga-FFD
Primary outcomes (1)
- measure
- Visual and standardized uptake values assessment of lesions and biodistribution
- timeFrame
- one month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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