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.
Study summary
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.
Eligibility
Sex
ALL
Min age
10 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Age ≥10 years.
* Histologically confirmed osteosarcoma.
* Relapsed or refractory disease following failure of first- or second-line systemic therapy.
* Ability to understand the study procedures and provide written informed consent (or assent with parental/legal guardian consent, where applicable).
Exclusion Criteria:
* Pregnant or breastfeeding.
* Severe uncontrolled systemic disease or medical condition that, in the investigator's judgment, may interfere with study participation or image interpretation.
* Unable to undergo PET/CT examination.
* Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Primary outcome measure(s)
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT — Baseline (at the time of PET/CT imaging) 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.
Number of participants with 68Ga-PFBH01-related adverse events — 30 ± 3 days 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).
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University First Hospital trials in China
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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