An Early Phase 1 interventional study of 68Ga-B7-H3 Nanobody PET/CT in Osteosarcoma and Osteosarcoma, Recurrent, Refractory, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Peking University First Hospital · Early Phase 1, Interventional, and Diagnostic
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Imaging findings will be compared with conventional imaging and, when available, histopathological results. The study will assess tracer biodistribution, tumor uptake, lesion detectability, and safety to determine the potential clinical value of B7-H3-targeted immunoPET for the diagnosis and evaluation of osteosarcoma.
B7-H3 (CD276) is an immune checkpoint molecule that is highly expressed in a variety of malignant tumors, including osteosarcoma, while showing limited expression in most normal tissues. Because of its high tumor-associated expression, B7-H3 has emerged as a promising molecular imaging and therapeutic target.
This is a prospective, single-center clinical study designed to evaluate a novel 68Ga-labeled B7-H3 nanobody as an immunoPET imaging agent in patients with osteosarcoma. Eligible participants will receive an intravenous administration of the investigational radiotracer followed by PET/CT imaging at the prespecified imaging time point(s). Safety assessments will include monitoring of adverse events and other clinically relevant evaluations as specified in the protocol.
Imaging findings will be analyzed to characterize tracer biodistribution and tumor uptake and will be compared with standard imaging examinations and histopathological findings whenever available. The study is intended to investigate the feasibility and diagnostic performance of 68Ga-B7-H3 nanobody immunoPET for the detection and evaluation of osteosarcoma and to provide clinical evidence supporting the further development of B7-H3-targeted molecular imaging.
Exclusion Criteria:
Participants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety.
Diagnostic Test: 68Ga-B7-H3 Nanobody PET/CT
Participants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety.
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
Number and proportion of osteosarcoma lesions detected by 68Ga-B7-H3 nanobody PET/CT, using histopathology and/or clinical follow-up as the reference standard.
Time frame: Baseline (at the time of PET/CT imaging)
Number of participants with 68Ga-PFBH01-related adverse events
Number and proportion of participants experiencing one or more adverse events considered related to 68Ga-PFBH01 administration. Adverse events will be recorded from tracer administration through 30 ± 3 days after PET/CT and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 30 ± 3 days
Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions
SUVmax of 68Ga-PFBH01 will be measured in osteosarcoma lesions identified on PET/CT. SUVmax represents the maximum voxel-level standardized uptake value within the lesion region of interest.
Time frame: At the time of PET/CT imaging ("Baseline")
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article will be shared, including relevant clinical characteristics and quantitative PET/CT imaging data. Data that could compromise participant privacy will not be shared.
Supporting information: Study protocol, Sap
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Peking University First Hospital