68Ga-B7-H3 Nanobody PET Imaging in Osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center early-phase study evaluates the safety and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for PET/CT imaging in patients with osteosarcoma. Eligible participants with suspected or confirmed osteosarcoma receive the radiotracer intravenously, followed by PET/CT at predefined time points. Imaging results will be compared with conventional imaging and available histopathology to assess tracer distribution, tumor uptake, and lesion detectability, with safety monitoring throughout. The goal is to determine feasibility and diagnostic value of B7-H3 targeted immunoPET for detection and evaluation of osteosarcoma and to support further development of this imaging approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Tingfei Gu, M.D
• Email: tingfei.gu@stx.ox.ac.uk
• Phone: 010-83572913

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.