68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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