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RECRUITING Early Phase 1 ClinicalTrials.gov

68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma

Sponsor: Peking University First Hospital • ClinicalTrials.gov ID: NCT07774533

Registry updated: 2026-08-19
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Description

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.

Interventions

  • 68Ga-B7-H3 Nanobody PET/CT (Diagnostic test)
    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.

Eligibility criteria

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.

Conditions

Osteosarcoma Osteosarcoma, Recurrent, Refractory

Locations

  • Peking University First Hospital — Beijing, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record