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.
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's planned enrollment of 16 is below the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, Statistical analysis plan
Time frame: Beginning 6 months after publication and available for 5 years.
Access criteria: De-identified individual participant data and supporting information may be made available to qualified researchers upon reasonable request for scientifically valid research purposes. Requests should be directed to the corresponding author and should include a research proposal describing the objectives and planned analyses. Access will be subject to review and approval by the study investigators and applicable institutional and ethical requirements. A data use agreement may be required before data are released. Data that could compromise participant privacy will not be shared.
Ran from Apr 2026 to primary completion in Aug 2026, 4 months.
Of 49 phase 1 interventional studies under Osteosarcoma, half reached primary completion within 77 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 134. This study's 4 months is below that.
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