68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age10-80
SponsorPeking University First Hospital
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 68Ga-B7-H3 Nanobody PET/CT
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov